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U.S. Department of Health and Human Services

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

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GEOMED MEDIZIN-TECHNIK GMBH & CO. KG CARB-BITE MAYO-HEGAR NEEDLE HOLDER Back to Search Results
Model Number 121135
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/15/2022
Event Type  malfunction  
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 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.
 
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.
 
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Brand Name
CARB-BITE MAYO-HEGAR NEEDLE HOLDER
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 Key16110153
MDR Text Key307889185
Report Number8010168-2023-00002
Device Sequence Number1
Product Code DWS
UDI-Device Identifier10381780377160
UDI-Public10381780377160
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,Followup
Report Date 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
Device Operator Health Professional
Device Model Number121135
Device Catalogue Number121-135 / AR 200-16-61
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/09/2022
Initial Date FDA Received01/05/2023
Supplement Dates Manufacturer Received01/10/2023
Supplement Dates FDA Received02/08/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2015
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 Age22 YR
Patient SexMale
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