MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 1.1MM NON-THREADED GUIDE WIRE 150MM

Model Number	292.623
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is company representative.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.
Event or Problem Description
It was reported that on an unknown date, the tip of a non -threaded guide wire broke during an unknown procedure.It was unknown if there was a surgical delay and adverse event to the patient reported.Patient outcome was unknown.This complaint involves (1) device.This report is for one (1) 1.1 mm non-threaded guide wire 150 mm.This is report 1 of 1 for (b)(4).
Event or Problem Description
It was further reported that there was a fragment caused by breakage of the wire and did add to the operation time.All pieces were retrieved and removed and confirmed upon x-ray exam.It was unknown if there was adverse event to the patient.
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.H10 additional narrative: b5, b6 h6 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 NON-THREADED GUIDE WIRE 150MM
• Common Device Name: GUIDE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 9123702
• Report Number: 2939274-2019-60892
• Device Sequence Number: 2332825
• Product Code: FZX
• UDI-Device Identifier: 10886982180735
• UDI-Public: (01)10886982180735
• 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
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

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: 292.623
• Device Catalogue Number: 292.623
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1