MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC INSERTION HANDLE/ RADIOLUCENT MEDIUM; SCREW, FIXATION, BONE

Model Number	03.043.021
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: additional product code: jds.Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is a j&j sales representative.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, the patient underwent a procedure during which the aiming arm hooks to both and snapped off.The drill bit was hitting the nail through the triple sleeves.Out of the 3 cases performed with the tna, 2 of 3 cases hit the nail with semi-extended para patellar approach.Procedure was completed successfully.Concomitant devices reported: unknown triple sleeves (part# unknown, lot# unknown, quantity# unknown).This report is for one (1) insertion handle/ radiolucent medium.This is report 4 of 4 for complaint (b)(4).

• Brand Name: INSERTION HANDLE/ RADIOLUCENT MEDIUM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 12514476
• Report Number: 2939274-2021-05704
• Device Sequence Number: 3375748
• Product Code: HWC
• UDI-Device Identifier: 10886982297204
• UDI-Public: (01)10886982297204
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201336
• 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): 08/24/2021

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: 03.043.021
• Device Catalogue Number: 03.043.021
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/24/2021
• Initial Report FDA Received Date: 09/22/2021
• 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: AIMING ARM/ RADIOLUCENT; UNK - DRILL BITS: TRAUMA; UNK - GUIDES/SLEEVES/AIMING: SLEEVE; UNK - NAIL HEAD ELEMENTS: TFNA HELICAL BLADE