MAUDE Adverse Event Report: DEPUY SPINE INC OC UNIV JOINT TORQUE DRIVER; DRIVER, PROSTHESIS

Catalog Number	288314000
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Visual examination of the torque driver did not feature any immediately observable defects.The driver was mechanically tested and was found to be out of specification.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.A definitive root cause for the torque driver being out of calibration cannot be positively determined.Although not proven, the most probable root cause for the over torquing of the driver can be attributed to lack of maintenance during its time in use.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.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, during routine incoming receiving inspection, 6.0 nm torque limiting handle was found to be out of specification.There was no patient involvement.

• Brand Name: OC UNIV JOINT TORQUE DRIVER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8797981
• Report Number: 1526439-2019-51836
• Device Sequence Number: 16257707
• Product Code: HWR
• UDI-Device Identifier: 10705034221847
• UDI-Public: 10705034221847
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Type of Report: Initial
• Report Date (Section B): 05/22/2019

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 Catalogue Number: 288314000
• Device Lot Number: GB102825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 07/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1