MAUDE Adverse Event Report: DEPUY SPINE INC TORQUE WRENCH HANDLE; ORTHOSIS,PEDICLE SPINAL FIXATION

Model Number	286200240
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: reporter is (b)(6).Without a lot number, the device history records review could not be completed as no product was received.The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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
Device report from (b)(6) reports an event as follows: it was reported an unknown date that the item was found damaged during regular loaner inspection process from torque testing procedure.There was no procedure and patient involvement are reported.This complaint involves one (1) device.This report is for (1) torque wrench handle this report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
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.H10 additional narrative: h3, h6: investigation summary: investigation flow: power tools/calibration.Visual inspection: the torque wrench handle (p/n: 286200240, sn #: (b)(6)) was returned and received at us cq.Upon visual inspection, there were scratches on the device and the etch on the device started to fade but have no impact on the device functionality.No other issues were observed with the returned device.Functional test: torque testing was performed on the returned device at sdc in (b)(6) canada.The highest torque of the device measured during calibration testing was 8.34 nm which was not within the specified torque range of the device, the torque test failed high.Document/specification review the current revision of drawings were reviewed.The complaint was confirmed.The device received failed high during torque test.Hence confirming the allegation.Investigation conclusion: the complaint condition was confirmed for the torque wrench handle (p/n: 286200240, sn#: (b)(6)).There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.The potential cause could be due to device maintenance.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot: as per 100673626, manufacturing record evaluation is not required as the reported event is not associated with the manufacturing process and/or the potential cause of the defect cannot be associated to manufacturing.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.

• Brand Name: TORQUE WRENCH HANDLE
• Common Device Name: ORTHOSIS,PEDICLE SPINAL FIXATION
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11057243
• Report Number: 1526439-2020-02458
• Device Sequence Number: 2876104
• Product Code: MNI
• UDI-Device Identifier: 10705034210995
• UDI-Public: 10705034210995
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K160879
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2020

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 Model Number: 286200240
• Device Catalogue Number: 286200240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Received by Manufacturer: 11/25/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 02/01/2021
• Patient Sequence Number: 1