MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2017-12-01 for BIOSTOP INSTRUMENT HOLDER 14-1 621AI06 manufactured by Depuy Ireland - 9616671.
[93874731]
(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
[93874732]
Surgeon: (b)(6). Procedure: reverse shoulder replacement. During the implantation of the biostop cement restrictor, we believe the implant holder may have stayed in the patient. We searched the instrument set up and could not locate it, so it may have stayed in the humerus due to the surgeon unscrewing the implant holder from the shaft rather than pulling straight back on the shaft leaving only the cement restrictor in place. This was realised once the cement had been applied and the implant was in situ. Surgeon was aware and not concerned due to it being sterile and in a non weight bearing position. Female patient aged (b)(6) years. No delay to surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1818910-2017-50569 |
| MDR Report Key | 7074705 |
| Report Source | FOREIGN |
| Date Received | 2017-12-01 |
| Date of Report | 2017-11-03 |
| Date of Event | 2017-11-03 |
| Date Mfgr Received | 2018-08-29 |
| Date Added to Maude | 2017-12-01 |
| 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 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5743725905 |
| Manufacturer G1 | DEPUY ORTHOPAEDICS, 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 | 0 |
| Brand Name | BIOSTOP INSTRUMENT HOLDER 14-1 |
| Generic Name | BIOSTOP INSTRUMENT HOLDER |
| Product Code | LZN |
| Date Received | 2017-12-01 |
| Catalog Number | 621AI06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY IRELAND - 9616671 |
| Manufacturer Address | LOUGHBEG RINGASKIDDY CO. CORK IN EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-01 |