MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 5.0MM SCHANZ SCREW BLUNTED TROCAR POINT 125MM; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	294.53
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes 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 that on (b)(6) 2021, during an unknown procedure, one (1) broad locking compression plate hole stripped and the locking hole did not engage, one (1) broad locking compression plate broke after excessive bending, and the pins of a eight (8) shanz screw blunted trocar point had a broken tips.The procedure was successfully completed with a three (3) minute surgical delay.There was no patient consequence.This report involves one (1) 5.0mm schanz screw blunted trocar point 125mm.This is report 10 of 10 for (b)(4).

• Brand Name: 5.0MM SCHANZ SCREW BLUNTED TROCAR POINT 125MM
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 11505603
• Report Number: 2939274-2021-01349
• Device Sequence Number: 14452264
• Product Code: KTT
• UDI-Device Identifier: 10886982181510
• UDI-Public: (01)10886982181510
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K122455
• 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): 02/19/2021

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: 294.53
• Device Catalogue Number: 294.53
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/17/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.5MM BROAD LCP® PLATE 7 HOLES/134MM; 4.5MM BROAD LCP® PLATE 8 HOLES/152MM; 5.0MM SCHANZ SCREW 100MM; 5.0MM SCHANZ SCREW 125MM