MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC WIRE GUIDE/2 HOLES 12.0/3.2MM FOR SUPRAPATELLAR; NAIL, FIXATION, BONE

Model Number	03.010.433
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure on an unknown date, the suprapatellar blue handled was over torqued and the guide was bent in the process.The surgeon wanted the whole entire construct replaced after the procedure.Another set was brought in the room the compensate of the bent guide construct.Procedure was completed with no delay.There was no patient consequence.This report is for a wire guide/2 holes 12.0/3.2mm for suprapatellar.This is report 4 of 4 for (b)(4).
Additional Manufacturer Narrative
Additional narrative: date of event is an unknown date in 2022.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.

• Brand Name: WIRE GUIDE/2 HOLES 12.0/3.2MM FOR SUPRAPATELLAR
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13604329
• Report Number: 2939274-2022-00672
• Device Sequence Number: 5856891
• Product Code: JDS
• UDI-Device Identifier: 10886982068743
• UDI-Public: (01)10886982068743
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K111667
• 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

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: 03.010.433
• Device Catalogue Number: 03.010.433
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/27/2022
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 12.0 PROTECTION SLV STR FOR 8-11 NAILS; 12.0 PROTECTION SLV STR FOR 8-11 NAILS; 12.0MM TROCAR/PEEK FOR SUPRAPATELLAR; 12.0MM TROCAR/PEEK FOR SUPRAPATELLAR; HNDL FOR PROTEC SLVS FOR SUPRAPATELLAR; HNDL FOR PROTEC SLVS FOR SUPRAPATELLAR; WIRE GUIDE/2 H 12.0/3.2 SUPRAPATELLAR
• Patient Sex: Unknown