MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-16 for MILTEX MALLET 11 16OZ 27-660 manufactured by Integra York, Pa Inc..
[31570347]
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
[31570348]
Customer initially reports device is defective. On (b)(6) 2015 customer reports the head of mallet broke off in use. No one hurt at this time but fear that could happen.
Patient Sequence No: 1, Text Type: D, B5
[34103758]
On 12/14/2015 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis: a mallet returned in used condition, with (b)(6) 2015 etched into handle. It is noticed there are scratches and dents of varying degrees on the mallet. Evaluation of the mallet shows that the head is securely attached to the handle and the weld is still intact. . Due to the wear, tear of the mallet and unable to confirm report. The complaint is unconfirmed; unable to confirm report. Device history evaluation - nonconforming product report / nonconforming material report history: there is no applicable nonconforming product report / nonconforming material report history. Variance authorization / deviation history: there is no applicable variance authorization / deviation history engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history. Corrective action preventive action history: there is no applicable corrective action preventive action history. Health hazard evaluation history: none. Conclusion: the complaint is unconfirmed; unable to confirm report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2015-00121 |
| MDR Report Key | 5226730 |
| Date Received | 2015-11-16 |
| Date of Report | 2015-11-03 |
| Date Mfgr Received | 2015-12-14 |
| Device Manufacturer Date | 2015-09-01 |
| Date Added to Maude | 2015-11-16 |
| 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 | MILTEX MALLET 11 16OZ |
| Generic Name | M10 - ORTHOPEDIC |
| Product Code | GFJ |
| Date Received | 2015-11-16 |
| Returned To Mfg | 2015-11-30 |
| Catalog Number | 27-660 |
| 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 | 2015-11-16 |