MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG GOLD-GRIP MAYO-HEGAR NEEDLEHOLDER T05 20CM; NEEDLE HOLDER

Catalog Number AR 200-20-01

Device Problems Fracture (1260); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The microscopic image of the jaw part reveals a deformation of the insert carrier material, possibly caused by the instrument falling on a hard surface.The device history record, including acceptance testing results, was reviewed and found to conform to specifications.Since the device was returned incomplete, i.E., without the broken-off tip insert, it is not possible to conclusively establish the cause of the fracture.

Event Description

During surgery, the needleholder insert broke at an angle across the tip on one of the blades.A section approx.2 mm long fell into the patient's wound.The fractured section was retrieved immediately.No patient harm.

• Brand Name: GOLD-GRIP MAYO-HEGAR NEEDLEHOLDER T05 20CM
• Type of Device: NEEDLE HOLDER
• 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
• MDR Report Key: 6787419
• MDR Text Key: 82763974
• Report Number: 8010168-2017-00002
• Device Sequence Number: 1
• Product Code: MDM
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AR 200-20-01
• Device Lot Number: G6
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2016
• 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 Outcome(s): Required Intervention