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 Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: investigation flow: damage.Visual inspection: the 1.1mm threaded guide wires 150mm (p/n: 292.622, lot #: 92p6373 & qty:1) were 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 lot # n/a, supplier batch # 30p3850, release to warehouse date: feb 23, 2021, expiration date: n/a, supplier: (b)(4), no ncr's were generated during production, part # 292.622, synthes lot # 92p6373, supplier lot # n/a, supplier batch # 30p3850, release to warehouse date: feb 23, 2021, expiration date: n/a, supplier: (b)(4), no ncr's were generated during production.Device history review: review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which 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 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 complaint involves four (4) devices.This report involves one (1) 1.1mm threaded guide wire 150mm.This is report 1 of 1 for (b)(4).

• 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: 12196055
• Report Number: 2939274-2021-04163
• Device Sequence Number: 14564906
• 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
• Report Date (Section B): 06/22/2021

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/20/2021
• Patient Sequence Number: 1