MAUDE Adverse Event Report: SYNTHES GMBH RADIOLUCENT DRIVE MARK II; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Model Number	511.30
Medical Device Problem Codes	Mechanical Jam (2983); Noise, Audible (3273); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pre-surgery testing it was observed that the radiolucent drive device was making a clicking sound, would not drive forward, and was hard to attach.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention, or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Udi :(b)(4).
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 this medwatch, a supplemental medwatch report will be filed as appropriate.H10 additional narrative: device evaluation update: the actual device was returned for evaluation.The radiolucent drive device was evaluated and the reported condition that the device was frozen/will not move was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device was making excessive noise, was difficult to assemble/disassemble, had vibration ¿ untrue running, and the etching was illegible.It was further determined that the device failed pretest for general condition, markings, check handpiece/attachment coupling, and general function in running mode.Therefore, the reported condition that the device was making a clicking sound, and was hard to attach was confirmed.The assignable root cause of this condition was determined to be traced to maintenance, which is improper maintenance.Correction h10: subsequent investigation was performed, which indicated that the reported condition that the device was frozen/will not move (would not drive forward) was not confirmed.Please note that the device evaluation has been updated to reflect this change.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, 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 this medwatch, a supplemental medwatch report will be filed as appropriate.The actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the radiolucent drive device was making excessive noise, was difficult to assemble/dis assemble, vibration ¿ untrue running, cosmetic damage, and did not function.It was further determined that the device failed pretest for general condition, markings, check handpiece/attachment coupling, and check general function in running mode.Therefore, the reported condition that the device was making a clicking sound, would not drive forward, and was hard to attach was confirmed.The assignable root cause of this condition was determined to be traced to maintenance, which is improper maintenance.

• Brand Name: RADIOLUCENT DRIVE MARK II
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 17088641
• Report Number: 8030965-2023-07311
• Device Sequence Number: 14154464
• Product Code: HWE
• UDI-Device Identifier: 10886982237385
• UDI-Public: 10886982237385
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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: 511.30
• Device Catalogue Number: 511.30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2023
• Supplement Date Received by Manufacturer: 07/26/2023; 07/27/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 07/27/2023; 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2015
• 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
• Patient Sex: Unknown