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

Model Number 275-525

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for inspection and the cause of the problem could not be established.Review of the device history record revealed no issues during manufacturing and confirmed that the device conformed to specifications at time of release.Review of device complaint history from 2016 to 2021 identified a single additional case of broken tc inserts among a total of more than 2,700 wire cutters placed in commercial distribution during the aforementioned period.

Event Description

A customer reported that the jaw of the wire cutter broke during an unspecified procedure and the fragments fell into the patient's body.There was a delay in surgery to find the fragments.All the broken pieces were removed and the surgery went well.The event occurred before (b)(6) 2021; the exact date is unknown.The doctors monitored the patient's condition post-surgery in case small invisible pieces remained in the body, potentially causing inflammation or other problems.Additional information was requested, but has not been forthcoming.

• 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, 78532 ; GM 78532
• Manufacturer (Section G): GEOMED MEDIZIN-TECHNIK GMBH & CO. KG; ludwigstaler strasse 27; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: hanno haug ; ludwigstaler strasse 27; tuttlingen, bw 78532 ; GM 78532
• MDR Report Key: 11878505
• MDR Text Key: 264089438
• Report Number: 8010168-2021-00001
• Device Sequence Number: 1
• Product Code: HXZ
• UDI-Device Identifier: 10381780385110
• UDI-Public: (01)10381780385110
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: EXEMPT
• 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: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 275-525
• Device Catalogue Number: 275515 / OL 505-22-01
• Device Lot Number: AA1903
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2019
• 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