MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-24 for LEWIN BONE HOLD CLAMP 7 225175 manufactured by Hebumedical Gmbh.
[93724236]
Return of the device was requested, but it had been scrapped and was therefore not available for evaluation and testing. Evaluation was based on a photograph of the damaged device and manufacturing records. It was manufactured in july 2016. Review of manufacturing records confirmed device conformance to specs at time of release. The photograph of the device confirmed breakage of the tip and signs of wear. Inappropriate use of the device by application of excessive force to the tips of the instrument may have caused the fracture. However, since the device was not returned it is not possible to conclusively determine the root cause of this failure.
Patient Sequence No: 1, Text Type: N, H10
[93724237]
The surgeon was using the lewin clamp during a right total hip arthroplasty to clamp down on patient's bone and the entire tip broke off. The broken piece was retrieved. No harm to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611112-2017-00005 |
| MDR Report Key | 7057920 |
| Date Received | 2017-11-24 |
| Date of Report | 2017-11-24 |
| Date of Event | 2017-08-29 |
| Date Mfgr Received | 2017-10-27 |
| Device Manufacturer Date | 2016-07-20 |
| Date Added to Maude | 2017-11-24 |
| 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 | MR. THOMAS BUTSCH |
| Manufacturer Street | BADSTRASSE 8 |
| Manufacturer City | TUTTLINGEN, 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78532 |
| Manufacturer G1 | HEBUMEDICAL GMBH |
| Manufacturer Street | BADSTRASSE 8 |
| Manufacturer City | TUTTLINGEN, 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | LEWIN BONE HOLD CLAMP 7 |
| Generic Name | CLAMP |
| Product Code | GDJ |
| Date Received | 2017-11-24 |
| Catalog Number | 225175 |
| Lot Number | 100088-1607 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEBUMEDICAL GMBH |
| Manufacturer Address | BADSTRASSE 8 TUTTLINGEN, 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-24 |