MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.1MM THREADED GUIDE WIRE 150MM; GUIDE, SURGICAL, INSTRUMENT

Model Number	292.622
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been 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 on unknown date, damaged product was received from the hospital.It is unknown how the issue was discovered.It is unknown if there was patient involvement.This report involves one (1) 1.1mm threaded guide wire 150mm.This is report 2 of 3 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).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: investigation summary: investigation flow: damage.Visual inspection: the 1.1mm threaded guide wire 150mm (p/n: 292.622, lot #: 92p6373 & qty:1) was returned and received at us cq.Upon visual inspection, it was observed that the guide wire is bent.Additionally, the device was received with breach in there inner packing tube and outer bags.No other issues were found on those guide wires.Device failure identified? yes, as device is bent.Document/specification review: based on the date of manufacture all related drawings are reflecting the current and manufactured revision were reviewed.Dimensional inspection: a dimensional inspection was not performed due to post-manufacturing damage.Complaint confirmed? yes, the complaint condition can be confirmed for guide wire being bent.Hence, conforming the allegation.Investigation conclusion the complaint condition can be confirmed for 1.1mm threaded guide wires 150mm (p/n: 292.622, lot #: 92p6373 & qty:1).During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.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 history lot part # 292.622, synthes lot # 92p6373, supplier batch # 30p3850.Release to warehouse date: feb 23, 2021, supplier: (b)(4).No ncr's were generated during production.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: 1.1MM THREADED GUIDE WIRE 150MM
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12031691
• Report Number: 2939274-2021-03075
• Device Sequence Number: 17065872
• Product Code: FZX
• UDI-Device Identifier: 10886982180728
• UDI-Public: (01)10886982180728
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

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: 292.622
• Device Catalogue Number: 292.622
• Device Lot Number: 92P6373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 07/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1