MAUDE Adverse Event Report: SYNTHES GMBH LARGE HANDLE WITH QUICK COUPLING; TAP, BONE

Catalog Number 311.431

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/24/2023

Event Type  malfunction  

Event Description

Device report from synthes reports an event in japan as follows: it was reported that on (b)(6) 2023, the patient underwent the primary surgery for the femur.Procedure was completed successfully without any surgical delay.On (b)(6) 2023, a removal surgery was performed with the handle and the extraction screw, since the bone union was achieved.During the removal of the df plate, the handle and the extraction screw broke.Procedure was completed successfully with sixty(60) minutes delay.No further information is available.This report is for one (1) large handle with quick coupling.This is report 1 of 2 for complaint (b)(4).

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.Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Initial reporter is a j&j sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.Part: 311.431.Lot: 2299478.Release to warehouse date: 24 nov 2011.Manufacturing site: werk selzach.Supplier: (b)(4).The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the handle w/quick-coupl was broken from the distal section of the handle where it assembles to the coupling, hence the components fell apart, all fragments were returned.The device presents light signs of fading of the brown color of the phenolic handle.These components can present this issue after several sterilization/cleaning cycles.The pouch in which the device was decontaminated and received prior to investigation presents light evidence of brown staining.The attached letter for sustaining engineering documents that the phenolic material, not this specific device, has been tested through numerous reprocessing cycles and slight color changes were noted but no signs of severe degradation such as bleeding or erosion were found.The returned instrument is over 11 years old and the slight fading noted on the phenolic handle would be expected for a device that has gone through numerous reprocessing cycles.A dimensional inspection for the handle w/quick-coupl was unable to be performed due to post manufacturing damage.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as the observed condition of the handle w/quick-coupl would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.If information is obtained that was not available for this medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LARGE HANDLE WITH QUICK COUPLING
• 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: 16380284
• MDR Text Key: 309606205
• Report Number: 8030965-2023-01869
• Device Sequence Number: 1
• Product Code: HWX
• UDI-Device Identifier: 07611819259836
• UDI-Public: (01)07611819259836
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 311.431
• Device Lot Number: 2299478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2011
• 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: EXTRACT-SCREW CONI F/SCR Ø4.5+6.5; UNK - PLATES: DISTAL FEMUR