MAUDE Adverse Event Report: DEPUY SPINE INC UNIPLATE CAM TGHTNR TORQ HNDL; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	289707000
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If the information is unknown, not available or does not apply, the section/field of the form is left blank.Initial reporter is synthes employee.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
It was reported that on an unknown date.During a routine incoming inspection of a loaner set, the torque handle was found to be out of drawing specification.The drawing specification is.63-.98.The torque tested at 1.62 which is above specification.There was no known patient or hospital involvement.This report is for one (1) uniplate anterior cervical plate system cam tightener torque handle.This is report 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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H3, h4, h6- the uniplate cam tgtnr torque handle (p/n: 289707000, lot #: e0209) was returned and received at us cq.Upon visual inspection, scratches and slight discoloration was observed consistent with the device use but has no impact on the device functionality.No other issues were identified with the returned device.The functional test was performed on the returned device at fsl owens & minor ashland, va site.The highest torque of the device measured during calibration testing was 1.62 nm which was not within the specified torque range of the device of.63 nm -.98 nm.Hence, the torque test failed high.The overall complaint was confirmed.No manufacturing issues were identified during an investigation.During the investigation, no product design issues or discrepancies were observed that may have contributed to the complaint condition.A root cause could not be determined, but it is likely the device was not properly maintained and has an internal mechanical failure.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot part # 289707000; lot # e0209.A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure no manufacturing record evaluation is required.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: UNIPLATE CAM TGHTNR TORQ HNDL
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9817486
• Report Number: 1526439-2020-00684
• Device Sequence Number: 3086995
• Product Code: LXH
• UDI-Device Identifier: 10705034224787
• UDI-Public: (01)10705034224787
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2020

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: 289707000
• Device Catalogue Number: 289707000
• Device Lot Number: E0209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2020
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1