Devices › Fastener, fixation, nondegradable, soft tissue
Device brand name · Fastener fixation nondegradable soft tissue
Healicoil Sa Pk 4 5mm W/2 Ub-Bl Cbrd Bl: medical device reports filed with FDA
207 reports name it, 2015–2026. Manufacturer given most often on reports: Smith & Nephew. Product code MBI.
- 207
- device reports naming the brand
- 0% of all MAUDE reports · about 18 a year
- 35
- reports, 12 months to August 2026
- 16 in the 12 months before
- 81.6%
- classified as malfunction
- 75.6% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
207 medical device reports received by FDA name the brand "Healicoil Sa Pk 4 5mm W/2 Ub-Bl Cbrd Bl" (fastener fixation nondegradable soft tissue); the manufacturer given most often on reports is Smith & Nephew; received from April 2015 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
35 reports arrived in the 12 months to August 2026, up 119% from 16 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are malfunction (81.6%) and injury (18.4%); across all fastener, fixation, nondegradable, soft tissue reports (product code MBI) death is recorded in 0% and malfunction in 75.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are break (55.1%), material separation (8.7%) and fracture (8.2%). The patient problems coded most often are foreign body in patient, perforation and device embedded in tissue or plaque. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 25,935 reports carrying product code MBI. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Breakthe device broke | 114 | 55.1% | 33.6% |
| Material separation | 18 | 8.7% | 1.5% |
| Fracturea broken bone | 17 | 8.2% | 5.7% |
| Corrodedthe device corroded | 8 | 3.9% | 0.2% |
| Device dislodged or dislocated | 8 | 3.9% | 5.9% |
| Material deformation | 6 | 2.9% | 1.4% |
| Detachment of device component | 5 | 2.4% | 1.3% |
| Detachment of device or device componentpart of the device came off | 4 | 1.9% | 3.1% |
| Material fragmentation | 4 | 1.9% | 1.5% |
| Bent | 2 | 1% | 0.4% |
| Component falling | 2 | 1% | 0.2% |
| Degraded | 2 | 1% | 0% |
| Delivered as unsterile product | 2 | 1% | 0.3% |
| Activation problem | 1 | 0.5% | 0.1% |
| Contamination | 1 | 0.5% | 0% |
| Crackthe device cracked | 1 | 0.5% | 0.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 1 | 0.5% | 0.9% |
| Device slipped | 1 | 0.5% | 0.6% |
| Loose or intermittent connection | 1 | 0.5% | 0.4% |
| Material integrity problema problem with the device material | 1 | 0.5% | 0.2% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Foreign body in patientpart of a device left in the patient | 9 | 4.3% |
| Perforation | 3 | 1.4% |
| Device embedded in tissue or plaque | 2 | 1% |
| Rupturethe device burst | 2 | 1% |
| Injurya physical injury | 1 | 0.5% |
| Local reaction | 1 | 0.5% |
| Painpain, site not specified | 1 | 0.5% |
| Swelling/ edema | 1 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Healicoil Sa Pk 4 5mm W/2 Ub-Bl Cbrd Bl | Product code MBI | All MAUDE reports |
|---|---|---|---|
| Reports | 207 | 25,935 | 26,136,888 |
| Share of that pool | — | 0.8% | 0% |
| Classified as death, per 1,000 reports | 0 | 0 | 9 |
| Classified as injury | 18.4% | 23.7% | 36.2% |
| Classified as malfunction | 81.6% | 75.6% | 62.3% |
| Filed by the manufacturer | 100% | 98.6% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code MBI
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Truespan 12 Degree Peek | 1,400 | 127 | 0% |
| Truespan 24 Degree Peek | 1,113 | 149 | 0% |
| Footprint Ultra Pk Suture Anchor 4 5 | 934 | 147 | 0% |
| KL 1.8 FiberTak, Shoulder | 682 | 222 | 0% |
| Rgdloop Adjustable Stnd | 519 | 81 | 0% |
| Twinfix Ultra Pk 4 5mm W/2 Ub -Wht &bl | 490 | 59 | 0% |
| Juggerstitch Curved Implant | 434 | 46 | 0% |
| Fibertak | 419 | 25 | 0% |
| Healicoil Knotless Pk Nst | 480 | 140 | 0% |
| Truespan Orthocord | 384 | 381 | 0% |
| Truespan 24 Degree Plga | 372 | 56 | 0% |
| Bone Anchor System For Soft Tissue Support | 331 | 0 | 0% |
| Omnispan Meniscal Repair 27deg | 714 | 161 | 0% |
| Truespan 12 Degree Plga | 320 | 65 | 0% |
| Truespan Meniscal Repair System Peek 12 Degree | 299 | 0 | 0% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about Healicoil Sa Pk 4 5mm W/2 Ub-Bl Cbrd Bl reports
How many FDA reports name Healicoil Sa Pk 4 5mm W/2 Ub-Bl Cbrd Bl?
207 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 35 in the latest 12 months.
What kinds of events are reported?
malfunction (81.6%) and injury (18.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
break (55.1%), material separation (8.7%), fracture (8.2%), corroded (3.9%) and device dislodged or dislocated (3.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Healicoil Sa Pk 4 5mm W/2 Ub-Bl Cbrd Bl was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.