MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2017-06-07 for UNKNOWN DRILL BIT N/A manufactured by Zimmer, Inc..
[76884442]
(b)(6). Kempton, laurence et al. ? A complication-based learning curve from 200 reverse shoulder arthroplasties". Reference journal article attached. (2011) 469:2496? 2504. The reported event was unable to be confirmed due to limited information received from the customer. A device history record review was unable to be performed as the lot number of the device involved in the event is unknown. A complaint history review was unable to be performed as the part and lot numbers are unknown. A root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. Initial reporter - the article was written by laurence b. Kempton, elizabeth ankerson, and j. Michael wiater. The complaint device is not expected for return currently, but a supplemental medwatch 3500a will be submitted upon receipt of additional information.
Patient Sequence No: 1, Text Type: N, H10
[76884443]
It was reported in a journal article that a drill bit had broken within the scapula and was left in situ. A new pathway was drilled for the screw. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2017-03923 |
| MDR Report Key | 6619002 |
| Report Source | LITERATURE |
| Date Received | 2017-06-07 |
| Date of Report | 2017-06-07 |
| Date Mfgr Received | 2017-05-11 |
| Date Added to Maude | 2017-06-07 |
| 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 | MS. CHRISTINA ARNT |
| Manufacturer Street | 56 E. BELL DR. |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal | 46582 |
| Manufacturer Phone | 5745273773 |
| Manufacturer G1 | ZIMMER, INC. |
| Manufacturer Street | 1800 WEST CENTER STREET |
| Manufacturer City | WARSAW IN 46580 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46580 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN DRILL BIT |
| Generic Name | INSTRUMENT, SHOULDER |
| Product Code | HWD |
| Date Received | 2017-06-07 |
| Model Number | N/A |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER, INC. |
| Manufacturer Address | 1800 WEST CENTER STREET WARSAW IN 46580 US 46580 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-06-07 |