MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC ENDPIECE WITH DOUBLE JOINT; APPARATUS, TRACTION, NON-POWERED

Model Number	394.44
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation could not be completed; no conclusion could be drawn, as no product was received.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 an unknown, during a routine incoming inspection of a loaner set, it was observed that the endpiece with double joint was broken.There was no known patient or hospital involvement.This report is for one (1) endpiece with double joint.This is report 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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.D10: device returned.H3, h6: the device was 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, h4, h6- the customer reported the device was broken.The repair technician reported the device cotter pin, chain, and connecting missing; spring nut missing.Missing parts is the reason for repair.The following parts were replaced: cotter pin, chain & connecting, and spring nut.The item is not repairable per the inspection sheet.The cause of the issue is no bom.The item will be forwarded to customer quality.The evaluation was confirmed.The device was received intact at cq.There were no issues found.Since the device was already repaired at service center and is being scrapped due to no bom being available, the complaint can be confirmed for the reported condition.The complaint was confirmed due to the details in the attached service and repair documentation.The device was repaired due to missing components of the endpiece with double joint.No definitive root-cause can be determined.The component may have gone missing during a sterilization cycle.During the investigation no unidentified product design/manufacturing issues or discrepancies 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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.No dhr can be completed since the lot number is unknown.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: ENDPIECE WITH DOUBLE JOINT
• Common Device Name: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9632555
• Report Number: 2939274-2020-00417
• Device Sequence Number: 3135561
• Product Code: HST
• UDI-Device Identifier: 10886982199720
• UDI-Public: (01)10886982199720
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 01/06/2020

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: 394.44
• Device Catalogue Number: 394.44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2020
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 01/17/2020; 02/20/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 02/12/2020; 02/26/2020
• Patient Sequence Number: 1