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

Model Number	286735725
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; 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) 2020, during an unknown procedure the surgeon was operating on a patient with very dense sclerotic bone.This was an index surgery.Proper technique was followed but the torque required to insert and adjust screws was incredibly high.During screw insertion and adjustment, several screw drivers were damaged.Fragments were generated and easily removed.There was a surgical delay of forty-five (45) minutes.There were no patient consequences.The procedure was successfully completed.Concomitant device reported: unknown screw (part# unknown, lot# unknown, quantity unknown) this complaint involves six (6) devices.This report is for (1) reduction shaft this is report 6 of 6 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.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 SHAFT
• Common Device Name: MISC ORTHO SURGICAL INSTR
• Manufacturer (Section D): DEPUY SPINE INC; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10672365
• Report Number: 1526439-2020-01948
• Device Sequence Number: 11445144
• Product Code: LXH
• UDI-Device Identifier: 10705034303499
• UDI-Public: 10705034303499
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2020

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: 286735725
• Device Catalogue Number: 286735725
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/22/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 11/11/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REDUCTION SHAFT; UNKNOWN SCREWS; VIPER2 T20 HEXLOBE DRIVER SHAF; XPDM QUICK-CON SI POLY SCWDRVR