MAUDE Adverse Event Report: DEPUY SPINE INC REDUCTION THREADED POST; MISC ORTHO SURGICAL INSTR

Model Number	286735730
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 on (b)(6) 2021, during pre-op for a procedure, the extensions had been cracked.The tip of the poly driver shaft was broken and unable to engage into the screw.Also, the threaded post of the x25 driver is not staying and continues to slide off.There were no patient consequences.The procedure outcome is unknown.Concomitant device reported.Unknown screws (part# unknown, lot# unknown, qty unknown).This complaint involves five (5) devices.This report is for (1) reduction threaded post.This report is 2 of 5 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.D9: complainant part is not expected to be returned for manufacturer review/ investigation.H3, h6: the investigation could not be completed, no conclusion could be drawn at the time of filing this report.The 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.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: REDUCTION THREADED POST
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 12470900
• Report Number: 1526439-2021-02013
• Device Sequence Number: 11707111
• Product Code: LXH
• UDI-Device Identifier: 10705034214665
• UDI-Public: 10705034214665
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2021

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: 286735730
• Device Catalogue Number: 286735730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Initial Date Received by Manufacturer: 08/17/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 09/14/2021
• Supplement Report FDA Received Date: 10/12/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: POLYAXIAL SCREW DRIVER SHAFT; UNKNOWN SCREWS; VIPER2 FINAL TIGHTENER DRIVER; VIPER2 SCREW EXTENSION, CLOSED; VIPER2 SCREW EXTENSION, CLOSED