MAUDE Adverse Event Report: SYNTHES GMBH INSERTION HANDLE FOR SUPRAPATELLAR; NAIL, FIXATION, BONE

Catalog Number	03.010.440
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Additional 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.H10 additional narrative: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.Product was not returned.Based on the information available, it has been determined that no corrective and 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.
Event or Problem Description
It was reported that on (b)(6) 2023, the patient underwent orif surgery for tibial diaphyseal fracture with expert tibial nai, insertion handle, connecting screw and screwdriver.Initially, the surgeon planned to use a tibial nail 9mm or larger, but because the patient's medullary cavity was narrow, the 8mm expert tibial nail was used.Approached from supra-patellar, the expert tibial nail was inserted after hammering with slightly more force.After fixing the distal hole, the proximal hole was fixed and then the connecting screw was turned to disconnect the nail from the insertion handle, but it could not be turned at all.The surgeon checked the image and could see that the nail top was deformed, and the insertion handle was stuck in the nail and tilted instead of aligned.Therefore, the surgeon connected the driving cap and driving head to the insertion handle and lightly tapped it out.The lateral image confirmed that the threads were fine, so the operation was completed with insertion of the end cap.Procedure was completed successfully with 30 minutes of surgical delay.No further information is available.This report is for one (1) insertion handle for suprapatellar.This is report 1 of 4 for complaint (b)(4).

• Brand Name: INSERTION HANDLE FOR SUPRAPATELLAR
• Common Device Name: NAIL, FIXATION, 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: 17313187
• Report Number: 8030965-2023-08690
• Device Sequence Number: 3995814
• Product Code: JDS
• UDI-Device Identifier: 07611819447936
• UDI-Public: (01)07611819447936
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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 Catalogue Number: 03.010.440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CONNECSCR CANN F/ETN F/SUPRAPATELLAR APP; EXPERT TN Ø8 W/PROX-BEND CANN L270 TAN D; SCRDRIVER-HEX W/SPHERIC-HEAD Ø8; UNK - END CAPS; UNK - INSERTION INSTRUMENTS: TRAUMA
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown