MAUDE Adverse Event Report: DEPUY SPINE INC UNIPL CAM TGHTNR SHFT TRI-LOBE; DRIVER, PROSTHESIS

Model Number	289706000
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device report from the united kingdom reports an event as follows: it was reported that during training on july 21, 2022, the torque screw driver was not clicking.There was no patient or procedure impact.This report is for a unipl cam tghtnr shft tri-lobe.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.Additional narrative: complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.Reporter is a synthes employee.A review of the receiving inspection (ri) for unipl cam tghtnr shft tri-lobe was conducted identifying that lot number gm5365301 was released in a single batch.Batch1: released on february 7, 2019 with no discrepancies.Supplier: (b)(4) medical: 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.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the device from the received image(s).Visual analysis of the photo revealed that there are no damage or defects with the unipl cam tghtnr shft tri-lobe.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was not confirmed for unipl cam tghtnr shft tri-lobe.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.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 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: UNIPL CAM TGHTNR SHFT TRI-LOBE
• Common Device Name: DRIVER, PROSTHESIS
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 15258957
• Report Number: 1526439-2022-01420
• Device Sequence Number: 17613944
• Product Code: HWR
• UDI-Device Identifier: 10705034224770
• UDI-Public: (01)10705034224770
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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: 289706000
• Device Catalogue Number: 289706000
• Device Lot Number: GM5365301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/21/2022
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNIPLATE CAM TGHTNR TORQ HNDL
• Patient Sex: Unknown