MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-01-08 for MBT REV TIB 2 DEG BROACH 37MM 217863111 manufactured by Depuy Orthopaedics, Inc..
[35431622]
(b)(4). This complaint is still under investigation. Depuy will notify the fda of the results of this investigation once it has been completed. 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
[35431646]
The tibial broaches will not lock in.
Patient Sequence No: 1, Text Type: D, B5
[38038928]
Conclusion and justification status for mdr: functional testing of the submitted device found the instrument to assemble, but requiring heavy manual force to compress the mbt rev tibial broaches "o" ring component enough to allow assembly. The "o" ring component was inspected and met material specifications. No corrective action is being pursued at this time based on no reported patient harms and the low frequency of reported events. Monitor through (b)(4). 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
| Report Number | 1818910-2016-10350 |
| MDR Report Key | 5354189 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-01-08 |
| Date of Report | 2015-12-11 |
| Date of Event | 2015-12-11 |
| Date Mfgr Received | 2016-01-27 |
| Device Manufacturer Date | 2005-01-15 |
| Date Added to Maude | 2016-01-08 |
| 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 | MBT REV TIB 2 DEG BROACH 37MM |
| Generic Name | KNEE INSTRUMENT/TRIAL |
| Product Code | LHX |
| Date Received | 2016-01-08 |
| Returned To Mfg | 2015-12-24 |
| Catalog Number | 217863111 |
| Lot Number | A0105 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2016-01-08 |