MAUDE Adverse Event Report: DEPUY SPINE INC TORQUE WRENCH HANDLE; MISC ORTHO SURGICAL INSTR

Model Number	286200240
Medical Device Problem Codes	Calibration Problem (2890); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # b)(4).Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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
Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient underwent for a revision surgery.During the revision surgery, the surgeon was doing an expedium 4.5 growing rod revision.It was noticed that handles have not been changed over 4 years.The surgeon suggested to change sfx torque and torque wrench handle.They¿re need to recalibrate.A few screwdrivers have been stripped in last couple of months.There were no patient consequences.Concomitant device reported: unknown rod (part# unknown, lot# unknown, quantity unknown).This complaint involves two (2) devices.This report is for (1) torque wrench handle.This report is 1 of 1 (b)(4).

• Brand Name: TORQUE WRENCH HANDLE
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11725553
• Report Number: 1526439-2021-00791
• Device Sequence Number: 17117187
• Product Code: LXH
• UDI-Device Identifier: 10705034210995
• UDI-Public: 10705034210995
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2021

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: 286200240
• Device Catalogue Number: 286200240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1