MAUDE Adverse Event Report: DEPUY SPINE INC TORQUE WRENCH HANDLE; MISC ORTHO SURGICAL INSTR

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
Reporter is jnj representative.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
Product complaint # (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.D11: concomitant products added to complaint.H6: investigation summary: background: the device did not meet specifications for torque testing.Investigation flow: power tools/calibration.Visual inspection: the torque wrench handle (p/n: 286200240, lot #: gb43367) was returned and received at us cq.Upon visual inspection, scratches were observed on the device and the etch of the device was faded but have no impact on the device functionality.No other issues were identified with the returned device.Functional test: a functional test was performed at raynham npd.The highest torque of the device measured during calibration testing was not within the specified torque range of the device, the torque test failed high.Document/specification review: dwg-887000832 rev c&e.The complaint was confirmed, the device received failed high during the torque test.Hence confirming the allegation.Investigation conclusion: the complaint condition is confirmed.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.H4, h6: device history lot: a review of the receiving inspection (ri) for torque wrench handle was conducted identifying that lot number gb43367 was released in a single batch.Batch1: lot qty of (b)(4) units were released on 18 sep 2012 with no discrepancies.As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history batch null, device history review: the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11057322
• Report Number: 1526439-2020-02459
• Device Sequence Number: 16862980
• Product Code: LXH
• UDI-Device Identifier: 10705034210995
• UDI-Public: 10705034210995
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• 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
• Device Lot Number: GB43367
• 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: 12/29/2020
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/19/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TORQUE WRENCH HANDLE