MAUDE Adverse Event Report: DEPUY SPINE INC SYMPHONY OCT SYSTEM REDUCTION TAB BREAKER; INSTRUMENT, CUTTING, ORTHOPEDIC

Model Number	2020-00-154
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	10/03/2022
Type of Reportable Event	Serious Injury
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.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.The investigation could not be completed; no conclusion could be drawn, as no product was received.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
Device report from synthes reports an event in japan as follows: it was reported that this was an unknown surgery performed on (b)(6) 2022.When the surgeon removed the tab of the reduction tab screw with the reduction tab breaker in question, the tab breaker slipped and contacted a nerve.Then, waveform did not appear in the mep monitoring at all.Although the surgeon waited for 15 minutes after saline solution was added to the surgical field, the mep monitoring did not show the waveform.A little additional decompression was performed, and the wound was closed.The surgery was completed successfully without any surgical delay.The patient was reported as stable.No further information is available.This report involves one symphony oct system reduction tab breaker.This is report 1 of 1 for (b)(4).

• Brand Name: SYMPHONY OCT SYSTEM REDUCTION TAB BREAKER
• Common Device Name: INSTRUMENT, CUTTING, ORTHOPEDIC
• 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: 15691487
• Report Number: 1526439-2022-01889
• Device Sequence Number: 15144483
• Product Code: HTZ
• UDI-Device Identifier: 10705034530642
• UDI-Public: 10705034530642
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 2020-00-154
• Device Catalogue Number: 202000154
• Device Lot Number: KM891047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2022
• Initial Report FDA Received Date: 10/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 65 KG