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

Model Number 121132

Device Problem Material Fragmentation (1261)

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

Event Date 06/30/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 307986410
• Report Number: 8010168-2022-00004
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 10381780377139
• UDI-Public: 10381780377139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Male