MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-11 for GERZOG MALLET 7-1/2 LEAD 19-790 manufactured by Integra York, Pa Inc..
[45151617]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[45151618]
Customer initially reports cracking and particles flaking of both sides of the mallet head upon use during the cases. On (b)(6) 2016, customer reports an open reduction of left fibula was being performed when minute particles were coming off device and into the wound. Doctor routine included preventative antibiotics. Wound irrigated with saline, no harm done.
Patient Sequence No: 1, Text Type: D, B5
[45607468]
On 5/4/16 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis - three mallets in used condition returned, not showing any unusual markings, showing wear, staining, dented and nicked. During visually inspecting the mallet, it is noticed that the head of the mallet is dented and nicked. Without knowing how the instruments were handled and used during use, the cause of the complaint is undetermined. The complaint report is confirmed. Device history evaluation - dhr review nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history. 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: none. Health hazard evaluation history: none. Conclusion: the root cause has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2016-00062 |
| MDR Report Key | 5648422 |
| Date Received | 2016-05-11 |
| Date of Report | 2016-04-19 |
| Date of Event | 2016-04-18 |
| Date Mfgr Received | 2016-05-04 |
| Device Manufacturer Date | 2014-07-01 |
| Date Added to Maude | 2016-05-11 |
| 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 | GERZOG MALLET 7-1/2 LEAD |
| Generic Name | M10 - ORTHOPEDIC |
| Product Code | HXL |
| Date Received | 2016-05-11 |
| Returned To Mfg | 2016-04-22 |
| Catalog Number | 19-790 |
| Lot Number | UNKNOWN |
| 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 | 2016-05-11 |