MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.25MM PLATE REDUCTION WIRE THRDD TIP W/LRG STOP/150MM; MISC ORTHO SURGICAL INSTR

Catalog Number	02.111.501.10
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient id: (b)(6).Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.: a review of the device history records 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 or Problem Description
It was reported that during an unknown procedure on (b)(6) 2018, a plate reduction wire broke and fragments were generated.The plate reduction wire and fragments were removed easily with no additional intervention.There was a surgical delay of two (2) minutes.The procedure was completed successfully and the patient status was reportedly satisfactory.This is report 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.A5: patient ethnicity is unknown.H3, h4, h6: investigation flow: broken.Visual inspection: visual inspection of the returned device performed at customer quality (cq) confirmed the condition of device breakage, which agrees with the reported complaint condition.The break occurred at the laser weld seam between the k-wire and limit stop components.The break is transverse and flush on the limit stop component surface.Visual inspection of the fracture surface under 10x magnification revealed no voids or abnormalities.It was also observed that the k-wire component has several bent areas.Document/specification review: a review of the device history records was unable to be performed since the lot number was unknown.Threaded large plate reduction wire assembly design drawing and k-wire component design drawing were reviewed during this investigation.Note on threaded large plate reduction wire assembly design drawing states "laser weld (all around).Functional seam, min.Torque 0.4 nm." no product design issues or discrepancies were observed.Dimensional inspection: the shaft diameter near location of breakage and bends measured ø1.23mm at cq (calipers ca592) which is within specification of ø1.25mm +0/-0.03mm.Material analysis: a relevant material analysis was not able to be performed at cq because the device broke at the laser weld seam, not within a single component material cross-section.Conclusion: a definitive root cause for the device breaking could not be determined based on the provided information.The bends that exist suggest that excessive force/rough handling has contributed to the device bending and ultimately breaking at the laser weld seam.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 as a result of this evaluation.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.
Event or Problem Description
Concomitant device: k-wire (part: unknown, lot: unknown, quantity: 1).

• Brand Name: 1.25MM PLATE REDUCTION WIRE THRDD TIP W/LRG STOP/150MM
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7679118
• Report Number: 2939274-2018-52820
• Device Sequence Number: 16532462
• Product Code: LXH
• UDI-Device Identifier: 20886982031706
• UDI-Public: (01)20886982031706
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2018

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 Catalogue Number: 02.111.501.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 08/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: THERAPY DATE: (B)(6) 2018
• Patient Age: 85 YR
• Patient Weight: 45