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

Model Number 03.835.032

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes 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 Description

It was reported that during a routine incoming inspection of a loaner set on an unknown date, the synfix evolution awl was observed to be broken.There were no patient and surgical involvement.This complaint involves one (1) device.This is 1 of 1 for report (b)(4).

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.Investigation flow: damage.Visual inspection: the synfix® evolution awl/without sleeve (part # 03.835.032 / lot # l479223) was received at us cq.There was no evidence of device breakage, the device appeared to be in good shape.Upon further inspection the awl component of the device was loose.Based on the device design, the awl should maintain position when held horizontal in all orientations.The awl freely moves along its hinges axis when held horizontally thus the device was deemed functionally loose.There does not appear to be any visual damage on the awls hinge.Although the device was found to be loose, the overall complaint of broken was not confirmed as there was no evidence of device breakage.Device failure/defect identified? yes; awl is loose.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 # l479223) as there was no device breakage.The device was found to be functionally loose when holding the device in the horizontal position.Although no definitive root-cause can be determined, it is possible the hinge of the device has worn out due to repetitive use, contributing to the loose 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 lot.Part: 03.835.032-us.Lot: l479223.Manufacturing site: hägendorf.Release to warehouse date: sept 21, 2017.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device history review.Review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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
• Type of Device: AWL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9273358
• MDR Text Key: 196115072
• Report Number: 2939274-2019-61943
• Device Sequence Number: 1
• Product Code: HWJ
• UDI-Device Identifier: 10705034814179
• UDI-Public: (01)10705034814179
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.835.032
• Device Catalogue Number: 03.835.032
• Device Lot Number: L479223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1