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 2018-05-31 for HAND SURGERY OSTEO 8MM 680016000 manufactured by Depuy Orthopaedic Inc, 1818910.
[109712974]
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
[109712975]
It was reported that the metal at the tip of osteotome broke on three different new osteotomes.
Patient Sequence No: 1, Text Type: D, B5
[113041827]
Product complaint # pc-(b)(4). Investigation summary examination of the returned instrument confirms the reported event. 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. 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
| Report Number | 1818910-2018-61055 |
| MDR Report Key | 7557967 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-31 |
| Date of Report | 2018-05-04 |
| Date Mfgr Received | 2018-06-26 |
| Device Manufacturer Date | 2016-02-17 |
| Date Added to Maude | 2018-05-31 |
| 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 | MR. CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DRIVE |
| Manufacturer City | WARSAW IN 465820988 |
| Manufacturer Country | US |
| Manufacturer Postal | 465820988 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDIC INC, 1818910 |
| 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 | HAND SURGERY OSTEO 8MM |
| Generic Name | MISCELLANEOUS JOINT INSTRUMENTS : EXTRACTION INSTRUMENTS |
| Product Code | HTR |
| Date Received | 2018-05-31 |
| Returned To Mfg | 2018-05-29 |
| Catalog Number | 680016000 |
| Lot Number | PG257824 |
| 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 ORTHOPAEDIC INC, 1818910 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-31 |