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 Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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
To whom it may concern: date j&j became aware: 05/07/19.Date of event: (b)(6) 2019, 4.30 pm.(b)(6).Product: uniplate torque driver.Lot/batch/exp: gm3504102.Product number: 28970600.Did the event happen during a procedure? yes.Were you in the procedure at the time of the event? yes.Was the product being used in a clinical trial? no.Event outcome/how was it managed? surgeon turned the driver round as it¿s double ended.Was there a patient impact or was the procedure due to the failure? no.Has the reporter facility indicated there may be legal action? no.Is the product available for return? yes once cleaned.Please give a detailed explanation of the event: surgeon inserter the torque driver into the indicated position on the plate when to turn the torque and the top snapped off in the camloc.The surgeon was able to suction the tip out so it was not left in the implant and possibly migrate in the patient.The surgeon used the other side of the driver to final tighten as it is double ended.This complaint involves one (1) device.
Additional Manufacturer Narrative
Product complaint #: (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.Device was not returned for evaluation.A review of the device history record could not be performed as the part number / lot number combination could not be found.Without the return of the device, we are unable to confirm the reported issue or identify the root cause.This complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # (b)(4).

• 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: 8837793
• Report Number: 1526439-2019-51890
• Device Sequence Number: 14100076
• Product Code: HWR
• UDI-Device Identifier: 10705034224770
• UDI-Public: (01)10705034224770
• Combination Product (Y/N): N
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/05/2019

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: 289706000
• Device Catalogue Number: 289706000
• Device Lot Number: GM3504102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/05/2019
• Supplement Date Received by Manufacturer: 08/16/2019; 09/23/2019; 09/24/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 08/27/2019; 09/23/2019; 09/25/2019
• 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: UNKNOWN PLATES; UNKNOWN SCREWS