MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DISTAL FEMUR LISS INSERTION GUIDE-LEFT; GUIDE, SURGICAL, INSTRUMENT

Model Number	324.011
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on unknown date, one pelvic reduction forcep, one liss insertion guide for distal femur, one depth gauge for locking screw, four universal chuck with t-handle, one cannulated 4.0mm hexagonal screwdriver, one pelvic reduction forcep, two ria drive shaft, one bending pliers, one forcep for broken screw removal, one locking plier, two large quick coupling, one depth gauge, one silicone handle, one red forceps serrated jaw ratchet, one plate holding forcep, one reduction forcep with point ratchet, one holding sleeve with wing screw, one graphic case and two graphic case for screw removal set were broken from usage.There was no patient consequence.This report involves one distal femur liss insertion guide-left.This is report 2 of 16 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.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.
Event or Problem Description
It was reported that on unknown date, one pelvic reduction forcep, one liss insertion guide for distal femur, one depth gauge for locking screw, four universal chuck with t-handle, one cannulated 4.0mm hexagonal screwdriver, one pelvic reduction forcep, two ria drive shaft, one bending pliers, one forcep for broken screw removal, one locking plier, two large quick coupling, one depth gauge, one silicone handle, one red forceps serrated jaw ratchet, one plate holding forcep, one reduction forcep with point ratchet, one holding sleeve with wing screw, one graphic case and two graphic case for screw removal set were broken from usage.There was no patient consequence.This report involves one distal femur liss insertion guide-left.This is report 2 of 16 for (b)(4).
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.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.
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.H10: additional narrative: a1, d9 h3, h4, h6: part 324.011-us, lot 9605884: manufacturing site: werk bettlach.Release to warehouse date: september 07, 2015.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.H3, h6: a service and repair evaluation was completed: the customer reported liss insertion guide for distal femur were broken from usage.The repair technician reported one of the holes where the thumb screw goes is stripped.Damaged component is the reason for repair.The item is not repairable per the inspection sheet.The cause of the issue is unknown.The evaluation was confirmed.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.H11: corrected data: b6, b7.

• Brand Name: DISTAL FEMUR LISS INSERTION GUIDE-LEFT
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK BETTLACH (CH); muracherstrasse 3; bettlach 2544 ; SZ 2544
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13584418
• Report Number: 2939274-2022-00607
• Device Sequence Number: 14545180
• Product Code: FZX
• UDI-Device Identifier: 10886982190918
• UDI-Public: (01)10886982190918
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial 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
• Operator of Device: Health Professional
• Device Model Number: 324.011
• Device Catalogue Number: 324.011
• Device Lot Number: 9605884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 02/23/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/07/2015
• 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