MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFIX EVOLUTION AWL/WITHOUT SLEEVE

Model Number	03.835.032
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter is a j&j employee.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.
Event or Problem Description
It was reported that on an unknown date, during a routine incoming inspection of the loaner set, it was observed that the synfix evolution awl without sleeve was broken.There was no patient involvement.This report is for 1 synfix® evolution awl/without sleeve.This is report 1 of 1 for complaint (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.Visual inspection: the synfix® evolution awl/without sleeve (part # 03.835.032 / lot # l319015) was received at us cq.There was no evidence of device breakage, the device appeared to be in good shape.Upon further inspection the distal end of the device was noticed to be deformed.Based on the device design, the tip should be sharp but the tip was bent and flat at the end.The overall complaint of broken was not confirmed as there was no evidence of device breakage.Device failure/defect identified? yes; tip was deformed.Dimensional inspection: no dimensional inspection was performed as there was no access to relevant components.Document/specification review: drawing(s) reviewed: (current & manufactured revisions).Conclusion: the overall complaint was not confirmed for the received synfix® evolution awl/without sleeve (part # 03.835.032 / lot # l319015) as there was no device breakage.Although no definitive root-cause can be determined, it is possible the tip of the device has worn out due to repetitive use, contributing to the deformed condition.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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.Device history: part number: 03.835.032, lot number: l319015, manufacturing site: hägendorf, release to warehouse date: 22.May 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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: SYNFIX EVOLUTION AWL/WITHOUT SLEEVE
• Common Device Name: AWL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10125397
• Report Number: 2939274-2020-02687
• Device Sequence Number: 2924672
• Product Code: HWJ
• UDI-Device Identifier: 10705034814179
• UDI-Public: (01)10705034814179
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2020

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: 03.835.032
• Device Catalogue Number: 03.835.032
• Device Lot Number: L319015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Initial Date Received by Manufacturer: 05/27/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 06/05/2020
• Supplement Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1