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

Catalog Number 511.300

Device Problems Complete Loss of Power (4015); Excessive Heating (4030)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

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.Concomitant med products and therapy dates: drill device, (b)(6) 2020.The reporter¿s phone number and complete facility address were not provided.The serial number was unknown; therefore, the device manufacture date is unknown.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Serial number unknown; (b)(4).

Event Description

It was reported from (b)(6) that during an open reduction internal fixation surgery for the right humeral shaft fracture, it was observed that during the drill for the distal screw, the surgeon made a pilot hole with the gimlet and drilled the front cortex successfully.However, during the opposite cortex drill, the drill device became idle.It was further reported that the surgeon removed the drill and the radiolucent drive device from the body once and cooled down the radiolucent drive with the saline.They tried to drill again; however, halfway through the process, the drill stopped.It was reported that the surgeon cooled down the device and drilled the cortex a few times and drilled the opposite cortex successfully.It was reported that the surgery was completed successfully with a thirty-minute-minute delay to the surgical procedure.It was not reported if a spare device was available for use.There was patient involvement reported.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 report will be submitted accordingly.

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.D4: serial number: the serial number was unknown in the initial report.The serial number has been updated as (b)(6).H4: device manufacture date: the device manufacture date was unknown in the initial report.The device manufacture date has been updated as 1/1/1900.Udi: (b)(4).

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.Service review: a review of the service history record indicates that the device has been serviced within the last year for a service condition that is not relevant to the current reported condition.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the reported condition that the device was heating was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, it was determined that the device had a cosmetic damage due to a worn coupling.It was further determined that the device passed all functional testing without failure.Visually, the cutting tool coupling failed the assessment due to a circular groove.It was determined that the issue was most likely due to the groove, which was caused by strong lateral forces applied to the drill device, causing the friction.It was further determined that the device failed pretest for check the tool coupling.The assignable root cause was determined to be traced to user, which is user error.

• Brand Name: RADIOLUCENT-DRIVE
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11101667
• MDR Text Key: 241251632
• Report Number: 8030965-2020-10073
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511.300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1