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 2017-10-04 for DISP NITINOL NDL SINGLE PACK N/A 110010851 manufactured by Zimmer Biomet, Inc..
[88159162]
Zimmer biomet complaint (b)(6). Reported event was unable to be confirmed due to limited information received from the customer. Dhr was reviewed and no discrepancies were found. Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided. A summary of the investigation has been sent to the complainant. 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
[88159163]
During the procedure, two sutures were successfully passed, but the nitinol needle fractured inside the mamba suture passer when the third suture was passed. A bipass suture passer was used to complete the procedure without significant delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-07877 |
| MDR Report Key | 6913567 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-10-04 |
| Date of Report | 2017-10-03 |
| Date of Event | 2014-08-12 |
| Date Mfgr Received | 2014-08-12 |
| Device Manufacturer Date | 2014-08-04 |
| Date Added to Maude | 2017-10-04 |
| 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 | DISP NITINOL NDL SINGLE PACK |
| Generic Name | SPORTS MED INSTRUMENTATION |
| Product Code | HXO |
| Date Received | 2017-10-04 |
| Model Number | N/A |
| Catalog Number | 110010851 |
| Lot Number | 139820 |
| ID Number | N/A |
| Device Expiration Date | 2019-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-10-04 |