MAUDE Adverse Event Report: GEOMED MEDIZIN-TECHNIK GMBH & CO. KG CARB-BITE MAYO-HEGAR NEEDLE HOLDER

Model Number	121135
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
Event or Problem Description
It was reported that the instrument was being used on the field in the patient's right leg during insertion of an intramedullary nail (femur).A piece of the tip was found in the leg while using c-arm during procedure.The piece was removed from the patient and placed in a specimen cup with lid.The instrument and specimen cup were immediately removed from the sterile field and given to circulator.An x-ray was taken to confirm that no retained objects remained.There was no consequence to patient as a result of the product problem and no procedural delay occurred.
Additional Manufacturer Narrative
The instrument was not returned and it was not possible to determine the manufacturing lot number.However, on the basis of the available information it was established that the device was manufactured in the second quarter of 2015.The device history records of all batches of the device that were manufactured during this period were reviewed.No problems were found.The device's complaint history was reviewed for the period from 2015 through 2022 and no problems were found.The investigation has been closed.Should additional information become known, the complaint will be reopened.

• Brand Name: CARB-BITE MAYO-HEGAR NEEDLE HOLDER
• 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: 16110153
• Report Number: 8010168-2023-00002
• Device Sequence Number: 2045135
• Product Code: DWS
• UDI-Device Identifier: 10381780377160
• UDI-Public: 10381780377160
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 02/08/2023

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: 121135
• Device Catalogue Number: 121-135 / AR 200-16-61
• 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: 12/09/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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 Age: 22 YR
• Patient Sex: Male