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 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.Without a lot number the device history records review could not be completed.Product was not returned.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 on an unknown date, the torque handle was tested and was outside of major range, it was testing at 101.15 n.M.Max range is.98 n.M.There was no patient involvement.This report is for one (1) uniplate cam tghtnr torq hndl.This is report 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.E3: j&j employee h3, h6: investigation summary product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.H3, h4, h6: a review of the device history record.Device history lot: km873406.A review of the receiving inspection (ri) for uniplate cam tghtnr torq hndl was conducted identifying that lot number km873406 was released in a single batch.Batch1: lot qty of 72 units were released on 13 dec 2018 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.H11: d4: lot number provided for reporting.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: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9586392
• Report Number: 1526439-2020-00365
• Device Sequence Number: 19442116
• Product Code: LXH
• UDI-Device Identifier: 10705034224787
• UDI-Public: (01)10705034224787
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 12/26/2019

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: KM873406
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/26/2019
• Supplement Date Received by Manufacturer: 12/26/2019
• Initial Report FDA Received Date: 01/14/2020
• Supplement Report FDA Received Date: 02/19/2020
• Patient Sequence Number: 1