MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC DRILL BIT/ CALIBRATED/ 4.2MM EXTRA-LONG; TEMPLATE

Model Number	03.045.022
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2021
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 on (b)(6) 2021, when the unknown tibial nail was inserted and the aiming arm was connected after, the unknown triple sleeve and unknown drill bit were inserted but missed the hole in the nail.The black tabs on the aiming arm were used to tighten down the aiming arm when a loud click happened.It was assumed it was in the correct position but after the drill bit still missed the hole, it was discovered that the aiming arm was cracked on one of the black tabs.A new aiming arm replaced the broken one.There was a ten minute surgical delay.The procedure was successfully completed.There was no patient consequence reported.This report is for (1) drill bit/ calibrated/ ø4.2mm extra-long.This is report 3 of 6 for (b)(4).

• Brand Name: DRILL BIT/ CALIBRATED/ 4.2MM EXTRA-LONG
• Common Device Name: TEMPLATE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12489139
• Report Number: 2939274-2021-05527
• Device Sequence Number: 14386537
• Product Code: HWT
• UDI-Device Identifier: 10886982292650
• UDI-Public: 10886982292650
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2021

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: 03.045.022
• Device Catalogue Number: 03.045.022
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2021
• Initial Report FDA Received Date: 09/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4.2MM TROCAR 210MM; AIMING ARM/ RADIOLUCENT; DRILL SLEEVE / 4.2MM; DRILL BIT/ CALIBRATED/ 4.2 EXTRA-LONG; PROTECTION SLEEVE/ 11/8; TIBIAL NAIL-ADVANCED / 10 315 / STERILE
• Patient Age: 34 YR
• Patient Weight: 104