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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYNTHES GMBH T-HANDLE CANN W/QUICK-COUPL HEX12; TAP, BONE

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SYNTHES GMBH T-HANDLE CANN W/QUICK-COUPL HEX12; TAP, BONE Back to Search Results
Catalog Number 03.010.496
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2023
Event Type  malfunction  
Event Description
It was reported that during a revision procedure, a nail was inserted.While inserting screws, the t-handle kept disengaging from the short power shaft, and the inner connecting element broke from malleting.Driver 03.045.003 and retention pin 03.045.004 also stripped/broke in the process of tightening the screw while malleting.After nailing, a va ppfx proximal femur plate was positioned due to the nail.The screw inserted with the cannulated hex driver was stripped due to the torque of the screwdriver.A handle swivel wrench was also used with the articulating tension device; two broke off due to pressure, so a solid one was used instead.There were no patient outcomes or consequences.Concomitant product details: unk - nails (part # unknown, lot # unknown, quantity - unknown), unk - plates: trauma (part # unknown, lot # unknown, quantity - unknown) this report is for one (1) t-handle cann w/quick-coupl hex12 this is report 6 of 9 for complaint.
 
Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j sales representative.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
T-HANDLE CANN W/QUICK-COUPL HEX12
Type of Device
TAP, BONE
Manufacturer (Section D)
SYNTHES GMBH
eimattstrasse 3
oberdorf 4436
SZ  4436
Manufacturer (Section G)
MONUMENT
1101 synthes avenue
monument CO 80132
Manufacturer Contact
kate karberg
1302 wright lane east
west chester, PA 19380
3035526892
MDR Report Key16869888
MDR Text Key314573235
Report Number8030965-2023-05763
Device Sequence Number1
Product Code HWX
UDI-Device Identifier07611819498945
UDI-Public(01)07611819498945
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
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 Catalogue Number03.010.496
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/19/2023
Initial Date FDA Received05/04/2023
Supplement Dates Manufacturer Received05/30/2023
Supplement Dates FDA Received06/12/2023
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
Treatment
CANNULATED 2.5MM HEXAGONAL SCREWDRIVER SHAFT.; RETENTION PIN SHORT XL25.; RETENTION PIN W/QUICK-COUPL HEX 12 SHORT.; SCRDRIVER SHORT XL25.; SOCKET WRENCH Ø 11.0 MM.; UNK - NAILS.; UNK - PLATES: TRAUMA.; UNK - SCREWS: TRAUMA.
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