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

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.

• 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 Key: 16869888
• MDR Text Key: 314573235
• Report Number: 8030965-2023-05763
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 07611819498945
• UDI-Public: (01)07611819498945
• 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: 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

• Date FDA Received: 05/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03.010.496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2023
• 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 Number: 1
• 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.