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 2018-08-22 for GUIDE WIRE GRIPPER N/A 00249001200 manufactured by Zimmer Biomet, Inc..
[117851998]
(b)(4). Concomitant medical product - tear drop guide wire 3. 0 mm diameter 100 cm length, cat#: 47249009700 lot#: 63836284; tear drop guide wire 3. 0 mm diameter 100 cm length, cat#: 47249009700 lot#: 63855457. (b)(6). Product has been returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Multiple mdr reports were filed for this event, please see all associated reports: 0001822565-2018-03636, 0001822565-2018-03226.
Patient Sequence No: 1, Text Type: N, H10
[117851999]
It was reported that during a femoral nailing procedure, the guide wire gripper would no longer grip the guide wire. No adverse events have been reported as a result of the malfunction. Attempts have been made and additional information on the reported event is unavailable at this time.
Patient Sequence No: 1, Text Type: D, B5
[132785911]
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. Inspection of the returned device revealed impaction marks present on the product. The 3. 0 mm hole exhibits wear indicative of use. The etching of the product is faded. The wear on the holes leads to insufficient gripping of guide wires. The part was measured within specifications. The functional check revealed that the gripper fails to grip the guide wire. Device history record was reviewed and no discrepancies relevant to the reported event were found. The gripper was used in-vivo in the field for approximately (b)(4) years. The root cause of the reported event is attributed to wear and tear due to normal use. 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
[132785912]
No further event information available at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001822565-2018-03636 |
| MDR Report Key | 7804616 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-08-22 |
| Date of Report | 2019-01-08 |
| Date of Event | 2018-05-09 |
| Date Mfgr Received | 2019-01-04 |
| Device Manufacturer Date | 2014-01-30 |
| Date Added to Maude | 2018-08-22 |
| 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 | GUIDE WIRE GRIPPER |
| Generic Name | PASSER, WIRE |
| Product Code | HXI |
| Date Received | 2018-08-22 |
| Returned To Mfg | 2018-06-20 |
| Model Number | N/A |
| Catalog Number | 00249001200 |
| Lot Number | 62597689 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2018-08-22 |