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 2018-03-23 for ATTUNE MOD POST SAW CAP SZ 6-8 254500046 manufactured by Depuy International Ltd - 8010379.
[103283563]
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
[103283564]
It was reported that the red plastic tab broke off the attune 6-8 capture. All pieces were retrieved from the patient.
Patient Sequence No: 1, Text Type: D, B5
[104604010]
Product complaint # pc-(b)(4). Investigation summary: examination of the returned device 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.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1818910-2018-55947 |
| MDR Report Key | 7365123 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-03-23 |
| Date of Report | 2018-03-05 |
| Date of Event | 2018-03-05 |
| Date Mfgr Received | 2018-04-03 |
| Device Manufacturer Date | 2015-03-06 |
| Date Added to Maude | 2018-03-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CHAD GIBSON |
| Manufacturer Street | 700 ORTHOPAEDIC DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY INTERNATIONAL LTD - 8010379 |
| Manufacturer Street | ST. ANTHONY'S ROAD |
| Manufacturer City | LEEDS LS118DT |
| Manufacturer Country | UK |
| Manufacturer Postal Code | LS11 8DT |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ATTUNE MOD POST SAW CAP SZ 6-8 |
| Generic Name | ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES |
| Product Code | LHX |
| Date Received | 2018-03-23 |
| Returned To Mfg | 2018-03-27 |
| Catalog Number | 254500046 |
| Lot Number | PG248711 |
| 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 INTERNATIONAL LTD - 8010379 |
| Manufacturer Address | ST. ANTHONY'S ROAD LEEDS LS118DT UK LS11 8DT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-23 |