MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG GOLD-GRIP CRILE-WOOD NEEDLEHOLDER T04 15CM

Catalog Number AR 220-15-61 / 121130

Device Problems Fracture (1260); Off-Label Use (1494); Dent in Material (2526); Device Handling Problem (3265)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The device history record, including acceptance testing results, was reviewed and found to conform to specifications.Microscopic inspection revealed dents caused by application of pressure to the outer surface of the jaw component, which indicates that the device may have been subject to inappropriate use.It must also be considered that the needle holder involved in the event is intended for cardiovascular surgery, not for orthopedic procedures.However, due to the fact that the device was returned incomplete, i.E., the broken-off tip is not available for inspection, it has not been possible to conclusively establish the cause of failure.

Event Description

According to the dealer, the instrument tip was broken during orthopedic surgery.No broken parts inside the patient.

• Brand Name: GOLD-GRIP CRILE-WOOD NEEDLEHOLDER T04 15CM
• Type of Device: NEEDLEHOLDER
• 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: 6197905
• MDR Text Key: 63067679
• Report Number: 8010168-2016-00006
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AR 220-15-61 / 121130
• Device Lot Number: 166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2016
• Date Manufacturer Received: 11/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2013
• 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