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

Catalog Number 511.300

Device Problems Mechanical Jam (2983); Noise, Audible (3273)

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

Event Date 07/01/2021

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: battery device, (b)(6) 2021.The reporter¿s phone number and complete facility address were not provided.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).

Event Description

It was reported from (b)(6) that during a fracture of a shaft of humerus surgical procedure, after inserting a nail, the surgeon fixed the proximal end of a nail with a screw and then tried to drill by inserting another screw to the distal end of the nail with the radiolucent drive device, it was discovered that the device worked when it was checked prior to drilling the bone.But when the surgeon began to drill the bone, the rotation slowed down in about five seconds.It was reported that the torque was applied to the device and it made a clicking sound and began to idle rotation.It was reported that although the surgeon changed the battery device and drilled carefully not to force on the radiolucent drive, the issue persisted.It was reported that after several attempts to drill over time, the same issue occurred and the problem could not be resolved, so the surgeon finally drilled manually and inserted the screw.There was a thirty-minute delay to the surgical procedure.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.H10 additional narrative: 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 relevant to the current reported condition.However, it was determined that the positive service history review alone was not sufficient to raise a capa.Device evaluation: this device was returned for evaluation.Quality engineering evaluated the device and determined that the device passed all visual inspections and pre-repair diagnostic assessments, and no failures were identified.Therefore, the reported condition was not confirmed, and an assignable root cause was not determined.

• 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: 12159498
• MDR Text Key: 268057606
• Report Number: 8030965-2021-05695
• Device Sequence Number: 1
• Product Code: HWE
• Combination Product (y/n): N
• PMA/PMN Number: K971544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• 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: 07/19/2021
• Date Manufacturer Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1