MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC REDUCTION WIRE/1.8MM DIAMETER 400MM LONG; APPLIANCE,FIXATION,NAIL

Model Number	03.311.042
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: flow: damage.Visual inspection: visual inspection of the returned device performed at customer quality (cq) shows device is bent at both the distal and proximal end.No new issues were identified.A device failure was identified.Document/specification review: the documents were reviewed as part of this investigation: based on the review of the above drawings, no design issues contributing to relevant complaint condition were identified.Conclusion: no definitive root cause was able to be determined as the circumstances surrounding the event are unknown, most likely excessive force was used during use resulting in the complaint condition.During the investigation no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot.Manufacturing location: supplier-(b)(4) / inspected, packaged and released by: (b)(4).Release to warehouse date: jun 07, 2019.Part number: 03.311.042, reduction wire/1.8mm diameter 400mm long.Lot number: u337934 (non-sterile).Lot quantity: (b)(4).Purchased finished goods traveler met all inspection acceptance criteria.Certificate of conformance supplied by (b)(4) dated 26-apr-2019 was reviewed and determined to be conforming.Inspection sheet, incoming final inspection met all inspection acceptance criteria.Packaging label log (pll), lmd rev a was reviewed and determined to be conforming.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Device history review.Mar 25, 2020: dhr reviewed.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that 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.
Event or Problem Description
It was reported that on (b)(6) 2020, the reduction wire was found not functioning during reverse logistics audit of returned device at millstone.There was no patient involvement.This complaint involves one (1) device.This is report 1 of 1 for (b)(4).

• Brand Name: REDUCTION WIRE/1.8MM DIAMETER 400MM LONG
• Common Device Name: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9959671
• Report Number: 2939274-2020-01825
• Device Sequence Number: 11488196
• Product Code: KTT
• UDI-Device Identifier: 10886982078032
• UDI-Public: (01)10886982078032
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K161417
• 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
• Report Date (Section B): 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 03.311.042
• Device Catalogue Number: 03.311.042
• Device Lot Number: U337934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 04/14/2020
• Patient Sequence Number: 1