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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Occupation: synthes sales rep.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.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 on an unknown date, they opened the sixteen (16) reduction wire to be added to an instrument set and it was noticed bent.There was no patient involvement.This complaint involves seven (7) devices.This report is for one (1) reduction wire/1.8mm diameter 400mm long.This report is 1 of 7 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 03.311.042, lot u292328: manufacturing location: supplier-(b)(4) / inspected, packaged and released by: monument.Release to warehouse dates: march 26, 2018 and april 10, 2018.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.A product investigation was completed: visual inspection noted a bent as-received condition along the wire's entire length.No other damage was noted.Dimensional inspection revealed all returned devices associated with this complaint measured within specification.The returned devices passed manufacturing inspection.The relevant drawing was reviewed during investigation.No design issues were noted.Review of the device's risk documents revealed this complaint condition is adequately covered by the risk assessment.The complaint was confirmed with investigation.There were no issues during the manufacture of this product that would contribute to this complaint condition.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.A root cause could not be determined during investigation; however, it is likely that the damage occurred during shipment and handling.This condition is adequately addressed by the device's production risk documentation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive 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: 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: 8558283
• Report Number: 2939274-2019-57703
• Device Sequence Number: 2256840
• Product Code: KTT
• UDI-Device Identifier: 10886982078032
• UDI-Public: (01)10886982078032
• Combination Product (Y/N): N
• PMA/510(K) Number: K161417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2019

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: 03.311.042
• Device Catalogue Number: 03.311.042
• Device Lot Number: U292328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 08/09/2019
• Patient Sequence Number: 1