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 2017-05-03 for ZIMMER NATURAL NAIL SYSTEM GUIDE WIRE GRIPPER N/A 00249001200 manufactured by Zimmer, Inc..
[74313377]
(b)(4). Customer has not indicated whether or not the product will 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.
Patient Sequence No: 1, Text Type: N, H10
[74313378]
It was reported that the wire gripper does not grip the wire. This issue was observed during sterilization and had no patient involvement. Therefore, no adverse events were reported as a result of the malfunction. No further information has been provided.
Patient Sequence No: 1, Text Type: D, B5
[133948175]
This follow-up report is being submitted to relay additional information. The following sections were updated: complaint sample was evaluated and the reported event was confirmed. A functional check was completed on the returned product with the mating guide wires. The hole does not securely grip the guide wire. Light impact marks as documented on attached print and detailed photos. 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. The most likely probably cause of the reported issue is wear and tear from use. There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation. 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
[133948176]
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2017-02915 |
| MDR Report Key | 6540966 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-05-03 |
| Date of Report | 2017-11-10 |
| Date of Event | 2017-04-04 |
| Date Mfgr Received | 2017-11-09 |
| Device Manufacturer Date | 2014-01-30 |
| Date Added to Maude | 2017-05-03 |
| 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 | ZIMMER NATURAL NAIL SYSTEM GUIDE WIRE GRIPPER |
| Generic Name | PASSER, WIRE |
| Product Code | HXI |
| Date Received | 2017-05-03 |
| Returned To Mfg | 2017-06-30 |
| Model Number | N/A |
| Catalog Number | 00249001200 |
| Lot Number | 62597689 |
| ID Number | N/A |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-05-03 |