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

Catalog Number	03.010.440
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/19/2024
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.D9: complainant part is not expected to be returned for manufacturer review/investigation.H6: photo investigation: the product was not returned to depuy synthes, however photos were provided for review.The photo investigation revealed that insert-handle f/etn f/suprapat approach had bent and the provided evidence was not sufficient to confirm the reported event of unable to assemble/disassemble.Functionality issues cannot be evaluated through a photo investigation.The observed condition of the device was consist with a random component failure that may have been caused by exposure to unintended force.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition of the insert-handle f/etn f/suprapat approach would contribute to the complained device issue.Based on the investigation findings, cause trace to component failure and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.The device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.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 during a procedure on (b)(6) 2024, it was identified that suprapatellar tn insertion arch has a dent.When it is coupled with the other arch it is very hard.It is left assembled since it was not possible to disassemble it.This report is for one (1) insertion handle for suprapatellar.This is report 1 of 1 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 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 19353496
• Report Number: 8030965-2024-06455
• Device Sequence Number: 7510037
• Product Code: JDS
• UDI-Device Identifier: 07611819447936
• UDI-Public: (01)07611819447936
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: Physician
• Type of Report: Initial

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
• 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: 04/22/2024
• Initial Report FDA Received Date: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown