MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC WASHER 13.0MM; BOLT,NUT,WASHER

Model Number	419.99
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no conclusion could be drawn at the time of filing this report.Product was not returned.Based on the information available, it has been determined that no corrective and 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.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
Hold for jg 5.11 it was reported that on (b)(6) 2021, patient underwent a pelvic surgery procedure for unknown reason.The titanium washer for 7.3mm cannulated screw broke during insertion.No fragments were generated.The procedure was completed successfully without surgical delay.There was no patient consequence.Concomitant device reported: unknown 7.3 cannulated screw (part# unknown; lot# unknown; quantity: 1).Unknown insertion instrument (part# unknown; lot# unknown; quantity: 1).This complaint involves one (1) device.This report is for (1) washer 13.0mm.This report is 1 of 1 (b)(4).

• Brand Name: WASHER 13.0MM
• Common Device Name: BOLT,NUT,WASHER
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11780049
• Report Number: 2939274-2021-02228
• Device Sequence Number: 3138758
• Product Code: HTN
• UDI-Device Identifier: 10886982214836
• UDI-Public: (01)10886982214836
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 04/09/2021

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: 419.99
• Device Catalogue Number: 419.99
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1