MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC AO COUPLING EXTENSION SHAFT; MISC ORTHO SURGICAL INSTR

Model Number	03.900.002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: event year is reported as 2020; however exact date of the event is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a j&j employee.Without a lot number the device history records review could not be completed.Product was not returned.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 during an unknown revision/removal procedure on an unknown date the ao coupling extension shaft broke off.No further information provided.This complaint is for one (1) ao coupling extension shaft.This is report 1 of 1 for complaint (b)(4).
Event or Problem Description
It was further reported that the patient underwent removal of a non depuy synthes implant due to failure.
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.H3, h6: the device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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: h3, h6: part: 03.900.002.Lot: 8960390.Manufacturing site: (b)(6).Release to warehouse date: (b)(6) 2014.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the proximal portion/tip of the device was found to be broken off and the broken piece was received.The complaints is confirmed the received condition is consistent with the complaint condition thus the complaint is confirmed.Dimensional inspection: the broken piece diameter at distal side was measured as 4.48mm (device(s) used:ca215p) which is within specification of 4.5+0/-0.04 mm.Conclusion: the complaint was confirmed.No definitive root cause was able to be determined as the circumstances surrounding the event are unknown.However, the received condition is consisted with exceeding lateral forces potentially form off-axis use or incomplete attachment of the mating attachments.During the investigation, no product design or manufacturing issues were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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: AO COUPLING EXTENSION SHAFT
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10163127
• Report Number: 2939274-2020-02855
• Device Sequence Number: 3300044
• Product Code: LXH
• UDI-Device Identifier: 10886982080646
• UDI-Public: (01)10886982080646
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.900.002
• Device Catalogue Number: 03.900.002
• Device Lot Number: 8960390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 06/17/2020; 07/17/2020
• Initial Report FDA Received Date: 06/17/2020
• Supplement Report FDA Received Date: 07/02/2020; 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1