MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 11MM TI CANNULATED TIBIAL NAIL-EX/405MM-STERILE; NAIL, FIXATION, BONE

Model Number	04.004.561S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.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 during a procedure on (b)(6) 2021, while drilling the proximal screw the drill bit hit the nail.The surgeon was able to target the hole and the screw was accurately placed.Checked postoperative and it was noted that the holes in the guide line up with the holes in the tibial nails.The procedure was successfully completed with no surgical delay reported.No patient consequence.This report is for (1) 11mm ti cannulated tibial nail-ex/405mm-sterile.This is report 4 of 4 for complaint (b)(4).

• Brand Name: 11MM TI CANNULATED TIBIAL NAIL-EX/405MM-STERILE
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12288975
• Report Number: 2939274-2021-04547
• Device Sequence Number: 17052902
• Product Code: JDS
• UDI-Device Identifier: 10886982084576
• UDI-Public: 10886982084576
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/08/2021

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: 04.004.561S
• Device Catalogue Number: 04.004.561S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 08/06/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.2 3-FLTD DRILL BIT QC/330/100 CALIB; AIMING ARM FOR SUPRAPATELLAR; INSERTION HANDLE FOR SUPRAPATELLAR; UNK - SCREWS: NAIL PROXIMAL LOCKING
• Patient Age: 58 YR