MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG GOLD GRIP WIRE CUTTER UP-ANGLED

Catalog Number 275-515 / OL 505-22-01

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

To date the device involved in the reported incident has not been received for evaluation.Manufacturer correction of user narrative: the cutting edges of the device are not silver-coated.The tip is provided with a tungsten carbide insert.The device history record, including acceptance testing results, was reviewed and found to conform to specifications.No complaints with regard to similar failures, i.E., peeling and flaking off of tungsten carbide tip, have been received neither for this type of device nor for other similar ones.Since the device is not available for testing and evaluation, it has not been possible to confirm the product problem nor to establish its cause.Device not returned by user.

Event Description

As per report provided by healthcare provider, while performing an open reduction internal fixation (orif) of a right ankle, it was noted that the pin cutters were peeling.The silver coating edge was peeling and flaking off.No patient injury.

• Brand Name: GOLD GRIP WIRE CUTTER UP-ANGLED
• Type of Device: WIRE CUTTER
• Manufacturer (Section D): GEOMED MEDIZIN-TECHNIK GMBH & CO. KG; ludwigstaler strasse 27; tuttlingen, baden-wuerttemberg 78532 ; GM 78532
• Manufacturer (Section G): GEOMED MEDIZIN-TECHNIK GMBH & CO. KG; ludwigstaler strasse 27; tuttlingen, baden-wuerttemberg 78532 ; GM 78532
• Manufacturer Contact: hanno haug ; ludwigstaler strasse 27; tuttlingen, baden wuerttemberg 78532 ; GM 78532 ; 746193550
• MDR Report Key: 6574650
• MDR Text Key: 75609919
• Report Number: 8010168-2017-00001
• Device Sequence Number: 1
• Product Code: HXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 275-515 / OL 505-22-01
• Device Lot Number: 1504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/13/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31 YR