MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM NON-COLORED THREADED GUIDE WIRE-SPADE POINT 230MM; WIRE, SURGICAL

Model Number	292.652
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: lxt, jdw.Reporter is a 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 during a routine incoming inspection on (b)(6) 2019, it was observed that the guide wire was bent.There was no patient involvement.This report is for a 2.0mm non-colored threaded guide wire-spade point 230mm.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.H10 additional narrative: h3, h6: part: 292.652; lot: h541446; part manufacturing date: january 18, 2018; manufacturing site: elmira; part expiration date: n/a; nonconformance noted: n/a.The device history record shows lot h541446 of 2.0 mm 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 h305941 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.Visual inspection: the 2.0 mm non-colored threaded guide wire ¿ spade point 230 mm was received at us customer quality (cq) with the guide wire bent closer to the distal portion of the device.This is consistent with the reported complaint condition, thus confirming the complaint.Dimensional inspection: dimensional analysis was completed.The diameter of the shaft measured within specification, based on drawing.Document/specification review: the following drawing was reviewed: 2 mm guide wire threaded 8 mm, spade point.Conclusion: there is no indication that a design or manufacturing issue contributed to the complaint.While no definitive root cause could be determined, it is possible that the device encountered unintended forces.No new malfunctions were observed during the course of this investigation.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: 2.0MM NON-COLORED THREADED GUIDE WIRE-SPADE POINT 230MM
• Common Device Name: WIRE, SURGICAL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 8619981
• Report Number: 2939274-2019-58126
• Device Sequence Number: 2182625
• Product Code: LRN
• UDI-Device Identifier: 10886982180766
• UDI-Public: (01)10886982180766
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2019

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: 292.652
• Device Catalogue Number: 292.652
• Device Lot Number: H541446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 05/17/2019
• Supplement Report FDA Received Date: 06/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1