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U.S. Department of Health and Human Services

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

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GEOMED MEDIZIN-TECHNIK GMBH & CO. KG CARB-BITE CRILE-WOOD NEEDLEHOLDER; NEEDLE HOLDER Back to Search Results
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.
 
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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 Key15798342
MDR Text Key307986410
Report Number8010168-2022-00004
Device Sequence Number1
Product Code DWS
UDI-Device Identifier10381780377139
UDI-Public10381780377139
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number121132
Device Catalogue Number121132 / AR 220-20-61
Device Lot Number100084-1703
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/17/2022
Initial Date FDA Received11/15/2022
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 Number1
Patient Outcome(s) Required Intervention;
Patient SexMale
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