MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2017-03-15 for RECLAIM TAPER TAMP 297500675 manufactured by Depuy Orthopaedics, Inc..
[69986249]
Examination of the returned instrument confirmed the complaint. The root cause is attributed to misuse. The surgical technique states to lightly tap the taper tamp with a mallet to engage the taper. This type of significant damage indicates the user did not lightly tap. A complaint database search finds no other reported incidents against the provided product and lot combination. The investigation could not verify or identify any product contribution to the reported event with the information provided. Based on the investigation, the need for corrective action is not indicated. Depuy considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Patient Sequence No: 1, Text Type: N, H10
[70067249]
This complaint is under investigation. Depuy will notify the fda of the results of the investigation once it has been completed. (b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10
[70067250]
Upon inspection in the sterile processing department, it was noticed that the reclaim taper tamp is damaged at the bottom and will not fit over the depth gauge used to implant the proxi-mal body portion. As a result, the product can no longer be used in surgery. Upon evaluation of the returned instrument it was found small pieces missing around the perimeter of the small opening.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2017-14669 |
| MDR Report Key | 6405372 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2017-03-15 |
| Date of Report | 2017-03-14 |
| Date of Event | 2017-01-16 |
| Date Mfgr Received | 2017-03-15 |
| Device Manufacturer Date | 2012-06-15 |
| Date Added to Maude | 2017-03-15 |
| 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 | CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46581 |
| Manufacturer Country | US |
| Manufacturer Postal | 46581 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RECLAIM TAPER TAMP |
| Generic Name | HIP INSTRUMENT/TRIAL |
| Product Code | HXG |
| Date Received | 2017-03-15 |
| Returned To Mfg | 2017-03-06 |
| Catalog Number | 297500675 |
| Lot Number | NB4247 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY ORTHOPAEDICS, INC. |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-15 |