MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-23 for 4.0MM FEMALE HEX DRIVER 2100-70-155 210070155 manufactured by Depuy Ireland - 9616671.
[184493699]
Product complaint # ==> (b)(4). Examination of the returned device confirmed the reported event. The damage is consistent with device use from normal use and servicing and the investigation did not establish a need for corrective action. Examination of the device found that the inside hex driver feature exhibits a crack, wear and stripping. There are cracks in the driver feature walls. There is no breakage or missing material. Depuy synthes considers the investigation closed at this time. Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary. 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
[184493700]
It was reported that the 4. 0mm green driver was? Stripped? According to surgeon customer. No surgical delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2020-08860 |
| MDR Report Key | 9866273 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2012-07-09 |
| Date Added to Maude | 2020-03-23 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KARA DITTY-BOVARD |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465810988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465810988 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, INC. 1818910 |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 465820988 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 4.0MM FEMALE HEX DRIVER |
| Generic Name | EXTREMITY INSTRUMENTS : SCREWDRIVERS |
| Product Code | HXX |
| Date Received | 2020-03-23 |
| Returned To Mfg | 2020-03-13 |
| Model Number | 2100-70-155 |
| Catalog Number | 210070155 |
| Lot Number | PG217705 |
| 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 IRELAND - 9616671 |
| Manufacturer Address | LOUGHBEG RINGASKIDDY CO. CORK EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |