MAUDE Adverse Event Report: DEPUY SPINE INC TORQUE WRENCH

Model Number 277040510

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The 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 Description

Libertas: it was reported that on (b)(6) 2019, the uniplate anterior cervical plate system cam tightener torque handle has failed during the calibration during reverse logistics audit of returned device at millstone.There was no patient involvement and no additional information is available.This complaint involves ten (10) devices.

Manufacturer Narrative

Product complaint #: (b)(4).Udi: (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.Investigation summary: the torque wrench [product code: 277040510, lot number: e0507] was not returned to the complaint handling unit (chu).Instead, the sample was returned to 5 star for rework and recalibration.Five star surgical, inc has performed the device evaluation for the torque wrench and provided the results to the complaints handling unit.It was noted that the device could not be adjusted to the other settings by hand.The torque wrench may be stuck at its current setting due to wear and/or rust to the internal components of the device, irregular maintenance, and lack of lubrication.A review of the device history record (dhr) could not be performed on the torque wrench (product code: 277040510, lot number: e0507) no manufacturing records could be located for this part/lot combination.If further information becomes available this dhr can be revisited.All complaint trends will be evaluated as a part of the depuy spine monthly complaint review meeting a definitive root cause for the torque wrench jamming cannot be positively determined.Although not proven, the most probable root cause of the torque wrench not being able to have its torque setting changed can be attributed to lack of maintenance during its time in use.No corrective action/preventive action (capa) is necessary now as no issues were identified in the manufacturing and release of this device that could have contributed to the problem reported by the customer.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.

• Brand Name: TORQUE WRENCH
• Type of Device: WRENCH
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9107689
• MDR Text Key: 178035275
• Report Number: 1526439-2019-52140
• Device Sequence Number: 1
• Product Code: HXC
• UDI-Device Identifier: 10705034196770
• UDI-Public: (01)10705034196770
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 08/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 277040510
• Device Catalogue Number: 277040510
• Device Lot Number: E0507
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1