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

Catalog Number	288314000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).One mountaineer oc universal joint torque driver was received by the customer quality unit.Visual examination at the macroscopic level revealed that the fracture was located at the driver¿s distal tip.The second half of the driver tip was not returned for analysis.The fracture analysis report reveals plastic deformation at the hexlobes and torsional shear markings following a circular pattern.This suggests that the fractured tip underwent a quasi-static overload torsional shear failure.The device history record identified no issues during the manufacturing and release of this instrument that could have contributed to the problem reported by the customer.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting.A definitive root cause for the torque driver¿s distal tip becoming fractured cannot be positively determined.However, the fracture analysis report suggests that the fractured tip underwent a quasi-static overload torsional shear failure.As no issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer.Additionally, no material defects or other abnormalities have been identified in the fracture analysis report.Therefore, 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 a torque handle 2883-14-000 ¿ lot gb70352 was returned to the charlotte nc fsl from hospital ((b)(4)) and inspected per inspection requirements.The torque driver could not be tested due to the star tip being not functional/worn.Required range: low-2.25nm, hi- 2.75nm.Actual result n/a, case # (b)(4), part# 2883-14-000, lot# gb70352, qty ¿ 1.

• Brand Name: OC UNIV JOINT TORQUE DRIVER
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SYNTHES SPINE; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7182060
• Report Number: 1526439-2018-50038
• Device Sequence Number: 988087
• Product Code: HWR
• UDI-Device Identifier: 10705034221847
• UDI-Public: 10705034221847
• 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
• Type of Report: Initial
• Report Date (Section B): 12/01/2017

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: GB70352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Initial Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 01/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1