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

Model Number	289706000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or 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.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 (b)(6) 2021, during an unknown procedure the surgeon was using the final tight driver for the uniplate system and the tip broke off.No harm to patient and the fragment was removed.There was no surgical delay.The procedure was successfully completed.This report is for one (1) uniplate anterior cervical plate system cam tightener shaft this is report 1 of 1 for complaint (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.H10 additional narrative: d4.H3, h4, h6: part: 289706000.Lot: g0207.Supplier: (b)(4).Batch 1 release to warehouse date: february 06, 2007, batch 2 release to warehouse date: february 06, 2007, batch 3 release to warehouse date: march 22, 2007.No nonconformance reports (ncrs) were generated during production.Visual inspection: unipl cam tghtnr shft tri-lobee was returned and received at us customer quality (cq).Upon visual inspection, the tip of the device was broken.Additionally, scratches were observed on the device.No other issues were observed with the returned device.Dimensional inspection: complaint relevant dimensions cannot be taken due to the post-manufacturing damage.Document/specification review: (current and manufactured) -double ended cam tightener, shaft uniplate no design issues or discrepancies were identified.Investigation conclusion: the complaint could be confirmed for the returned device.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 unintended forces applied on the device.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.D9.

• 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
• MDR Report Key: 12252417
• Report Number: 1526439-2021-01567
• Device Sequence Number: 3635864
• Product Code: HWR
• UDI-Device Identifier: 10705034224770
• UDI-Public: (01)10705034224770
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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: G0207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2021
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 08/13/2021
• Initial Report FDA Received Date: 07/30/2021
• Supplement Report FDA Received Date: 09/08/2021
• 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: UNKNOWN SCREWS; UNKNOWN TORQUE DEVICES; UNKNOWN SCREWS; UNKNOWN TORQUE DEVICES
• Patient Age: 66 YR