MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC HOLDING SLEEVE 105MM; GUIDE, SURGICAL, INSTRUMENT

Model Number	394.46
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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 (1) pelvic reduction forcep, one (1) liss insertion guide for distal femur, one (1) depth gauge for locking screw, four (4) universal chuck with t-handle, one (1) cannulated 4.0mm hexagonal screwdriver, one (1) pelvic reduction forcep, two (2) ria drive shaft, one (1) bending pliers, one (1) forcep for broken screw removal, one (1) locking plier, two (2) large quick coupling, one (1) depth gauge, one (1) silicone handle, one (1) red forceps serrated jaw ratchet, one (1) plate holding forcep, one (1) reduction forcep with point ratchet, one (1) holding sleeve with wing screw, one (1) graphic case and two (2) graphic case for screw removal set were broken from usage.There was no patient consequence.This report involves one (1) holding sleeve 105mm.This is report 16 of 16 for (b)(4).
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.A service and repair evaluation was completed.The customer reported, holding sleeve with wing screw were broken from usage.The repair technician reported, wing nut is broken off and missing.Device is broken and part is stuck inside item.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.

• Brand Name: HOLDING SLEEVE 105MM
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13585274
• Report Number: 2939274-2022-00624
• Device Sequence Number: 5731277
• Product Code: FZX
• UDI-Device Identifier: 10886982199744
• UDI-Public: 10886982199744
• 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: 394.46
• Device Catalogue Number: 394.46
• 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
• 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