MAUDE Adverse Event Report: SYNTHES GMBH CHUCK KEY/DRILL SPEED FOR TRAUMA RECON; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 05.001.206

Device Problems Vibration (1674); Mechanical Jam (2983); Complete Loss of Power (4015)

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

Event Date 02/24/2021

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.Additional narrative: the actual device was returned for evaluation.The chuck with key device was evaluated and the reported condition the device was exhibiting noticeable and excessive/uncomfortable vibration was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was observed that the device was frozen/would not move and did not function.The assignable root cause of this condition was determined to be traced to component failure due to normal wear.Udi (b)(4).

Event Description

It was reported from (b)(6) that during service and evaluation, it was determined that the chuck of the chuck with key device had seized, the device was frozen/would not move, did not function, had component damage, and moving parts of the device did not move smoothly.It was further determined that the device failed pretest for check the drill chuck, check function of the tool coupling, and check the free movement.It was noted in the service order that the device was exhibiting noticeable and excessive/uncomfortable vibration, with the catching paws inside the chucks seeming to be unstable and not working.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.

• Brand Name: CHUCK KEY/DRILL SPEED FOR TRAUMA RECON
• Type of Device: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6107428552
• MDR Report Key: 11711193
• MDR Text Key: 247233230
• Report Number: 8030965-2021-02945
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819977860
• UDI-Public: 07611819977860
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05.001.206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2021
• Date Manufacturer Received: 04/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1