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

Model Number	275-525
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: WIRE CUTTER
• Manufacturer (Section D): GEOMED MEDIZIN-TECHNIK GMBH & CO. KG; ludwigstaler strasse 27; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 11878505
• Report Number: 8010168-2021-00001
• Device Sequence Number: 17062462
• Product Code: HXZ
• UDI-Device Identifier: 10381780385110
• UDI-Public: (01)10381780385110
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 05/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention