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

Model Number	288900050
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that on an unknown date the torque handle was tested multiple times and each time it showed that it was out of tolerance.There was no patient involvement.This report is for one torque driver handle.This is report 1 of 1 for (b)(4).

• Brand Name: TORQUE DRIVER HANDLE
• Common Device Name: MISC. ORTHO SURGICAL INSTR.
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9834909
• Report Number: 1526439-2020-00720
• Device Sequence Number: 3068549
• Product Code: LXH
• UDI-Device Identifier: 10705034222868
• UDI-Public: (01)10705034222868
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/18/2020

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 Expiration Date: 10/03/2005
• Device Model Number: 288900050
• Device Catalogue Number: 288900050
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/18/2020
• Initial Report FDA Received Date: 03/16/2020
• Patient Sequence Number: 1