MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.8MM THREADED GUIDE WIRE 450MM/TROCAR POINT/300MM CALIB; SCREW, FIXATION, BONE

Model Number	900.726
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procodes: hrs, hty, jdw.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.A device history record review 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, the customer received a bent threaded guide wire.Surgeon said they are unable to use the device.There was no patient involvement.This report is for a 2.8mm threaded guide wire 450mm.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.Visual inspection: visual inspection of the returned device performed at customer quality (cq) confirmed the condition of a bent device, which agrees with the reported complaint condition.The wire is bent in several locations inside the undamaged packaging bag.The clear poly packaging bag is not compromised or damaged.Dhr review: a review of the device history record revealed no complaint related anomalies.The device history record shows lot h747465 of threaded guide wires was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.It can be conclusively determined that the wire was bent due to rough handling/transit.Therefore, further investigation will not be conducted.Investigation conclusion: it can be conclusively determined that the wire was bent due to rough handling/transit.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.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 history lot: part number: 900.726.Lot number: h747465.Part manufacturing date: 20 september 2018.Manufacturing site: elmira.Part expiration date: n/a.Nonconformance noted: n/a.A review of the device history record revealed no complaint related anomalies.The device history record shows lot h747465 of threaded guide wires was processed through the normal manufacturing and inspection operations with no rework or nonconformances noted.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.A review of the raw material device history record(s) determined the raw material lot h615759 met all specifications with no issues documented that would contribute to this complaint condition.A review of the device history record revealed no complaint related anomalies.This lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture 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.

• Brand Name: 2.8MM THREADED GUIDE WIRE 450MM/TROCAR POINT/300MM CALIB
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8344003
• Report Number: 2939274-2019-56483
• Device Sequence Number: 13932179
• Product Code: HWC
• UDI-Device Identifier: 10886982256362
• UDI-Public: (01)10886982256362
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K982222
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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: 900.726
• Device Catalogue Number: 900.726
• Device Lot Number: H747465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 02/15/2019
• Supplement Report FDA Received Date: 03/15/2019
• Patient Sequence Number: 1