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 2018-02-28 for SIGMA HP SYSTEM HANDLE 202499111 manufactured by Depuy Orthopaedics Inc Us 1818.
[101253085]
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
[101253086]
It was reported that the sigma hp system handle broke at the tip. No surgical delay.
Patient Sequence No: 1, Text Type: D, B5
[113040197]
Product complaint # ==> pc-(b)(4) investigation summary ==> examination of the returned instrument confirmed the reported event. Depuy considers the investigation closed. 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
[113445095]
Product complaint #: (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
| Report Number | 1818910-2018-54308 |
| MDR Report Key | 7304042 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-02-28 |
| Date of Report | 2018-02-21 |
| Date of Event | 2018-02-21 |
| Date Mfgr Received | 2018-04-13 |
| Device Manufacturer Date | 2009-09-15 |
| Date Added to Maude | 2018-02-28 |
| 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 ORTHOPAEDICS INC US 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 | SIGMA HP SYSTEM HANDLE |
| Generic Name | KNEE INSTRUMENT : HANDLES |
| Product Code | LHX |
| Date Received | 2018-02-28 |
| Returned To Mfg | 2018-03-09 |
| Catalog Number | 202499111 |
| Lot Number | A0909 |
| 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 US 1818 |
| Manufacturer Address | 700 ORTHOPAEDIC DRIVE WARSAW IN 465820988 US 465820988 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-28 |