MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC SYNFIX® EVOLUTION SCREWDRIVER

Model Number	03.835.010
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
Synthes employee.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.
Event or Problem Description
It was reported that on an unknown date, during routine incoming inspection, it was observed that the screwdriver was broken.There was no known patient or hospital involvement.This report is for 1 of 1 for (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.Part number: 03.835.010.Synthes lot number: 9945477.Manufacturing site: hägendorf.Release to warehouse date: 12.July 2016.A review of the device history record(s) and the non conforming report showed that there was no issues during the manufacture of the product, that would contribute to this complaint condition "device borken".Visual inspection: the synfix® evolution screwdriver (p/n 03.835.010 lot 9945477) was received showing a portion of the distal tip nicked.The complaint condition is not confirmed.Device failure/ defect identified? yes, the tip of the screwdriver is nicked.Dimensional inspection: the ø 3.2258mm tip of the screwdriver got measured.Drawing: stardrive straight driver blades.Outer diameter: ø 3.2258 +/- 0.1mm.Measured diameter = ø 3.23 mm.Conclusion: the measuring result does show conformity.No product design issues or discrepancies were observed during this investigation document/ specification review: the following drawing(s) was reviewed: screw driver synfix evolution screw.Screw driver shaft synfix evolution screw.Drawing: stardrive straight driver blades.A review of the manufacturing record evaluations was performed for the finished device lot number, and no non-conformances were identified.Complaint confirmed? no.Investigation conclusion: a definitive assignable root cause for the post manufacturing damage could not be determined based on the provided information.This complaint is confirmed however no product design issues or manufacturing discrepancies that would contribute to the reported complaint condition were identified during this investigation.No new, unique or different patient harms were identified because of this evaluation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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: SYNFIX® EVOLUTION SCREWDRIVER
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9246909
• Report Number: 2939274-2019-61789
• Device Sequence Number: 306045
• Product Code: HXX
• UDI-Device Identifier: 10705034814117
• UDI-Public: (01)10705034814117
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2019

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: 03.835.010
• Device Catalogue Number: 03.835.010
• Device Lot Number: 9945477
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1