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 2015-12-03 for ANGLED ACET INSERTR 920010029 manufactured by Depuy Orthopaedics, Inc..
[32625452]
(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
[32625453]
A piece chipped out of the poly handle of the inserter and was lost at the hospital.
Patient Sequence No: 1, Text Type: D, B5
[33120162]
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
[36808504]
Additional narrative: conclusion and justification status: territory 208 reports a piece chipped out of the poly handle of the inserter and was lost at the hospital. Conclusion and justification status: the complaint states a piece chipped out of the poly handle of the inserter and was lost at the hospital. The investigation confirmed that the angled acet inserter handle had fractured as reported. Previous investigations have found that design change was implemented for this product ((b)(4)) to prevent the anti-rotation pin from loading the plastic handle to minimise further failures of the handle cracking. (b)(4) was created to investigate the use of radel in instruments and concluded that the data showed no systematic failures of extruded radel for use in instruments. Following the dra a hhe was completed ((b)(4)) and concluded that the risk is medium and that no further action is necessary. The complaint shall be closed with a justified conclusion it will be entered into the complaint database and monitored through trend analysis. Depuy still 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 | 1818910-2015-36497 |
| MDR Report Key | 5264841 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2015-12-03 |
| Date of Report | 2015-12-01 |
| Date of Event | 2015-12-01 |
| Date Mfgr Received | 2016-01-22 |
| Device Manufacturer Date | 2012-04-06 |
| Date Added to Maude | 2015-12-03 |
| 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 | ANGLED ACET INSERTR |
| Generic Name | HIP INSTRUMENT/TRIAL |
| Product Code | LHX |
| Date Received | 2015-12-03 |
| Returned To Mfg | 2015-12-07 |
| Catalog Number | 920010029 |
| Lot Number | P25002001 |
| 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 | 2015-12-03 |