MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,health pr report with the FDA on 2018-02-06 for GUIDE WIRE GRIPPER N/A 00249001200 manufactured by Zimmer Biomet, Inc..
[99126314]
(b)(4). Report source: foreign. The event occurred in (b)(6). Customer has indicated that the product is in process of being returned to zimmer biomet for investigation. Once the investigation has been completed, a follow-up mdr will be submitted. Not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[99126315]
It was reported the wire gripper was no longer gripping the wire. The surgery was completed with another device without delay. No further information is available at this time.
Patient Sequence No: 1, Text Type: D, B5
[125993523]
This follow-up report is being submitted to relay additional information. Complaint sample was evaluated and the reported event was confirmed. Inspection of the returned device revealed impact marks and scratches on the impaction surface. Both holes exhibit heavy gauging and wear indicative of use. Also noted impaction marks on the product. The wear on the holes leads to insufficient gripping of guide wires. Device history record (dhr) was reviewed and no discrepancies were found relevant to the reported event. Investigation results concluded the root cause of the event is normal wear during the instrument's field life. 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 | 0001822565-2018-00648 |
| MDR Report Key | 7244487 |
| Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
| Date Received | 2018-02-06 |
| Date of Report | 2018-04-16 |
| Date of Event | 2018-01-07 |
| Date Mfgr Received | 2018-04-16 |
| Device Manufacturer Date | 2015-07-16 |
| Date Added to Maude | 2018-02-06 |
| 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, ORTHOPEDIC |
| Product Code | HXI |
| Date Received | 2018-02-06 |
| Returned To Mfg | 2018-03-05 |
| Model Number | N/A |
| Catalog Number | 00249001200 |
| Lot Number | 63107373 |
| ID Number | (01) 00889024063136 |
| Operator | PHYSICIAN |
| 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 | 2018-02-06 |