MAUDE Adverse Event Report: DEPUY SPINE INC TORQUE WRENCH HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	286200240
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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 (b)(6) 2019, that the point of torque wrench shaft was spinning in set screw head, they had to change to alternative instruments.There was evidence of wear at the hex of the torque shaft.It is unknown if there were procedure and patient involvement.Concomitant device reported: unknown screw (part # unknown, lot # unknown, quantity unknown).This complaint involves one (1) device.
Additional Manufacturer Narrative
(b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual examination of the returned device revealed superficial wear in the form of discoloration, nicks and scuff marks on its surface.The torque wrench was mechanically tested and was within required specifications.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.The investigation could not verify or identify any evidence of the device contribution to the reported problem.It is not suspected that the device failed to meet its specifications.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.

• Brand Name: TORQUE WRENCH HANDLE
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8689737
• Report Number: 1526439-2019-51746
• Device Sequence Number: 16733996
• Product Code: LXH
• UDI-Device Identifier: 10705034210995
• UDI-Public: (01)10705034210995
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

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 Model Number: 286200240
• Device Catalogue Number: 286200240
• Device Lot Number: GB0608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2019
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 06/11/2019
• Supplement Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1