MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-10-12 for LEWIN BONE HOLD CLAMP 7 225175 manufactured by Integra York, Pa Inc..
[90312442]
On 9/28/2017 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - the instrument has not been returned, the investigation is based on the picture supplied in the parent record. Device history evaluation - dhr review nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: there is no applicable. Engineering change order/manufacturing change order history. Corrective action preventive action history/corrections: none. Health hazard evaluation history: none. Conclusion: there was one picture supplied to us for this investigation. The picture of the lewin bone hold clamp shows wear. The complaint report of broken has been confirmed; we cannot determine the root cause without the instrument being returned for our investigation.
Patient Sequence No: 1, Text Type: N, H10
[90312443]
Customer initially reported that the surgeon was using the lewin clamp to clamp down on patients bone and the entire tip broke off once clamped. No patient injury. On 9/21/2017 customer reports device broke during a right total hip arthroplasty, piece retrieved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00091 |
| MDR Report Key | 6946145 |
| Report Source | USER FACILITY |
| Date Received | 2017-10-12 |
| Date of Report | 2017-09-19 |
| Date of Event | 2017-08-29 |
| Date Mfgr Received | 2017-10-17 |
| Device Manufacturer Date | 2016-07-01 |
| Date Added to Maude | 2017-10-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEWIN BONE HOLD CLAMP 7 |
| Generic Name | N/A |
| Product Code | GEN |
| Date Received | 2017-10-12 |
| Returned To Mfg | 2017-10-16 |
| Catalog Number | 225175 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-12 |