MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-12-05 for BIPASS DISPOSABLE NITINOL 10 PK N/A 902094 manufactured by Zimmer Biomet, Inc..
[93682797]
(b)(4). Report source, foreign? Events occurred in (b)(6). Customer has been indicated that the product will not be returned to zimmer biomet for investigation. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted. Hospital discarded as biohazard.
Patient Sequence No: 1, Text Type: N, H10
[93682798]
It was reported that during a rotator cuff repair, the nitinol pusher fractured inside of the patient, causing the surgeon to have to retrieve the broken piece. No further patient consequences were reported. Attempts have been made and additional information on the reported event is unavailable.
Patient Sequence No: 1, Text Type: D, B5
[120465190]
This follow-up report is being submitted to relay additional information. Reported event was confirmed by review of photos. Two pictures are provided for evaluation. The tip of the nitinol pusher shaft appears to be fractured. Device history record was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no trends were identified. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly. Zimmer biomet will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001825034-2017-10774 |
| MDR Report Key | 7082027 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-12-05 |
| Date of Report | 2018-01-12 |
| Date of Event | 2017-11-02 |
| Date Mfgr Received | 2018-01-11 |
| Device Manufacturer Date | 2017-04-11 |
| Date Added to Maude | 2017-12-05 |
| 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 BIOMET, INC. |
| Manufacturer Street | 56 E. BELL DRIVE |
| Manufacturer City | WARSAW IN 46582 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 46582 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIPASS DISPOSABLE NITINOL 10 PK |
| Generic Name | PUSHER, SOCKET |
| Product Code | HXO |
| Date Received | 2017-12-05 |
| Model Number | N/A |
| Catalog Number | 902094 |
| Lot Number | 834650 |
| ID Number | SEE H10 NARRATIVE |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZIMMER BIOMET, INC. |
| Manufacturer Address | 56 E. BELL DRIVE WARSAW IN 46582 US 46582 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-12-05 |