MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC PERCUTANEOUS RADIOLUCENT INSERTION HANDLE; ROD,FIXATION,INTRAMEDULLARY

Model Number	03.037.112
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event occurred on an unknown date in 2020.Complainant part is not expected to be returned for manufacturer review/investigation.Occupation: reporter is a j&j employee.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.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 on an unknown date during an unknown procedure, the insertion handle and two (2) 5mm flexible screwdriver broke.The 2.7mm va-lcp lateral distal fibula plate was stripped and unable to be locked with the coupling screw.It is unknown if there was a surgical delay.Procedure outcome was not reported.Patient status is unknown.This report is for one (1) percutaneous radiolucent insertion handle.This is report 1 of 4 for (b)(4).

• Brand Name: PERCUTANEOUS RADIOLUCENT INSERTION HANDLE
• Common Device Name: ROD,FIXATION,INTRAMEDULLARY
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11229693
• Report Number: 2939274-2021-00472
• Device Sequence Number: 3512221
• Product Code: HSB
• UDI-Device Identifier: 10886982070562
• UDI-Public: 10886982070562
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K131548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/04/2021

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: 03.037.112
• Device Catalogue Number: 03.037.112
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 01/26/2021
• Patient Sequence Number: 1