MAUDE Adverse Event Report: DEPUY SPINE INC UNIPLATE CAM TGHTNR TORQ HNDL; MISC ORTHO SURGICAL INSTR

Model Number	289707000
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Patient Involvement (2645)
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.Reporter is a depuy 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 during routine incoming inspection of a loaner set on an unknown date, it was observed that the torque handle was found to be out of drawing specification.There was no patient involvement.When the device was received for investigation, a viper2 tightener handle was also present.Concomitant devices: viper2 tightener handle (part: 286745500, lot: gb109636, quantity: 1).This report is for a cam tightener torque handle.This is report 1 of 1 for (b)(4).
Additional 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.Visual examination found the device to be worn as evidenced by surface scratches and discoloration.The noted defects were consistent with normal wear of the device.No other defects were noted.The device was then functionally tested and found to be out of specification.A manufacturing related potential cause was not suspected, therefore, no manufacturing record evaluation is required.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.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.

• Brand Name: UNIPLATE CAM TGHTNR TORQ HNDL
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9341790
• Report Number: 1526439-2019-52456
• Device Sequence Number: 2801577
• Product Code: LXH
• UDI-Device Identifier: 10705034224787
• UDI-Public: (01)10705034224787
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 10/30/2019

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: 289707000
• Device Catalogue Number: 289707000
• Device Lot Number: E0508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2019
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VIPER2 FINAL TIGHTENER HANDLE