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 2016-08-02 for GUIDE WIRE GRIPPER 00249001200 manufactured by Zimmer, Inc..
[50980253]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[50980254]
It was reported that the surgeon tried to insert the wire into the guide wire gripper, but the wire was not being gripped.
Patient Sequence No: 1, Text Type: D, B5
[54545797]
This report will be amended when our investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[57834250]
Device history records were reviewed with no deviations or anomalies identified that would have contributed to the reported event. The guidewire gripper was returned for review. Visual inspection revealed impact marks on the superior surface. A functional check confirmed that the 2. 4mm hole securely gripped a 00/47-2255-008-00 guide wire, but the 3. 0 mm hole failed to securely grip a 00/47-2255-008-01 guide wire. The threaded locking knob was also observed to bind. This device is used for treatment. Based on the order running complete, it is believed the part was conforming when it left zimmer biomet. The instrument/provisional use, care and sterilization package insert states to inspect all product and? If damage or wear is noted that may compromise the function of the instrument, do not use the device and contact your zimmer representative for a replacement?. The guidewire gripper was manufactured on 30 jan 2014 and therefore had potential field age of approximately 2 years 4 months, with the exact usage unknown. The most likely cause of the instruments not gripping is wear and tear from use.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 0001822565-2016-02608 |
MDR Report Key | 5841314 |
Report Source | DISTRIBUTOR,FOREIGN,HEALTH PR |
Date Received | 2016-08-02 |
Date of Report | 2016-07-05 |
Date of Event | 2016-06-28 |
Date Mfgr Received | 2016-10-10 |
Device Manufacturer Date | 2014-01-30 |
Date Added to Maude | 2016-08-02 |
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. CARRIE SCHNEIDER |
Manufacturer Street | P.O. BOX 708 |
Manufacturer City | WARSAW IN 465810708 |
Manufacturer Country | US |
Manufacturer Postal | 465810708 |
Manufacturer Phone | 8006136131 |
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 | GUIDE WIRE GRIPPER |
Generic Name | TRAUMA INSTRUMENT |
Product Code | HXI |
Date Received | 2016-08-02 |
Returned To Mfg | 2016-08-23 |
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, INC. |
Manufacturer Address | 1800 WEST CENTER STREET WARSAW IN 46580 US 46580 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2016-08-02 |