MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFIX® EVOLUTION AIMING DEVICE HOLDER; IMPACTOR

Model Number 03.835.004

Device Problem Mechanical Jam (2983)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Part returned.A synthes representative.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.A review of the device history record has been requested.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 on (b)(6) 2019, the synfix evolution aiming device holder was broken when it was taken out of the synfix evolution sets for inspection prior to case. the device  was discovered broken/jammed prior to going through sterile processing department (spd).There was no case nor patient impact as there was another aiming device holder that could use. this complaint involves one (1) device.This report is 1 of 1 for (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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6- synfix® evolution aiming device holder was received at cq in 3 components.Upon visual inspection at cq, it is observed that the device shows minimal wear which would not contribute to the complaint condition.The flange on the core part cpl was bent inwards, which is not contributing to reported condition.The internal features of the locking sleeve cpl were deformed which might affect the functionality of the device.Visual inspection, dimensional inspection, and document specification review of the received device was performed at cq.The complaint is confirmed as there is issue with device interaction, but the reported broken condition cannot be confirmed.A definitive root cause could not be determined.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.Device history lot: part: 03.835.004; lot: l196426; manufacturing site: hägendorf; release to warehouse date: 25.November 2016.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 AIMING DEVICE HOLDER
• Type of Device: IMPACTOR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8790897
• MDR Text Key: 151127979
• Report Number: 2939274-2019-59185
• Device Sequence Number: 1
• Product Code: HWA
• UDI-Device Identifier: 10705034814100
• UDI-Public: (01)10705034814100
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03.835.004
• Device Catalogue Number: 03.835.004
• Device Lot Number: L196426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Date Manufacturer Received: 07/16/2019
• Patient Sequence Number: 1