MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG CARB-BITE CRILE-WOOD NEEDLEHOLDER; NEEDLE HOLDER

Model Number	121132
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During an open reduction internal fixation right distal radius and scaphoid fracture, the needle holder broke in the wound.All pieces were found and visualized.Two x-rays were taken, confirming that there was no foreign body in wound.No patient injury, death or surgical delay was reported.
Additional Manufacturer Narrative
Despite several attempts to obtain the device or photographs of the device, the needle holder was not returned.Therefore, it was impossible to perform an evaluation of the device or to determine the batch code of the device, although the lot number reveals that it was manufactured either on august 1 or on september 7, 2017.No issues were found in the corresponding device history records, confirming that device conformed to specifications at time of release.

• Brand Name: CARB-BITE CRILE-WOOD NEEDLEHOLDER
• Common Device Name: NEEDLE HOLDER
• 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: 15798342
• Report Number: 8010168-2022-00004
• Device Sequence Number: 4791084
• Product Code: DWS
• UDI-Device Identifier: 10381780377139
• UDI-Public: 10381780377139
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/15/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 121132
• Device Catalogue Number: 121132 / AR 220-20-61
• Device Lot Number: 100084-1703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2022
• Initial Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male