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 2017-09-28 for BIPASS PLASTIC NITINOL DISP X1 N/A 902093 manufactured by Zimmer Biomet, Inc..
[87877996]
Zimmer biomet complaint (b)(4). (b)(4). Product has been received by zimmer biomet. Complaint sample was evaluated and the reported event was confirmed. The failure mode was general handling damage. The product functioned as intended and did not cause any major delay or risk to patient. The dhr was reviewed and no discrepancies were found. Review of the complaint history determined that no further action is required as no were trends identified. The investigation results concluded that the reported event was due to customer error. 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
[87877997]
Bipass suture punch bent during surgery. Another bipass suture punch was used to complete the procedure. This caused a delay of approximately 10 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001825034-2017-07423 |
| MDR Report Key | 6901124 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-09-28 |
| Date of Report | 2017-09-27 |
| Date of Event | 2014-10-13 |
| Date Mfgr Received | 2014-10-13 |
| Device Manufacturer Date | 2014-05-06 |
| Date Added to Maude | 2017-09-28 |
| 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 PLASTIC NITINOL DISP X1 |
| Generic Name | PUSHER, SOCKET |
| Product Code | HXO |
| Date Received | 2017-09-28 |
| Returned To Mfg | 2014-11-19 |
| Model Number | N/A |
| Catalog Number | 902093 |
| Lot Number | 135910 |
| Device Expiration Date | 2014-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-09-28 |