MAUDE Adverse Event Report: SYNTHES GMBH CHUCK WITH KEY F/BPL; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Catalog Number 530.730

Device Problem Mechanical Jam (2983)

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

Event Date 01/01/2021

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.Additional narrative: the actual device was returned for evaluation.During repair, an evaluation was performed and it was determined that the device was frozen/would not move.Therefore, the reported condition was confirmed.The assignable root cause of this condition was determined to be traced to component failure due to wear.Udi: (b)(4).

Event Description

It was reported from (b)(6) that during service and evaluation, it was determined that the chuck with key device had component damage and the chuck seized was frozen/would not move.It was further determined that the device failed pretest for check the drill chuck.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention, or prolonged hospitalization.The exact date of the event was not reported, however, it was reported that the event occurred in 2021.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: CHUCK WITH KEY F/BPL
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): SYNTHES PRODUKTIONS GMBH; hauptstrasse 24; waldenburg 4437 ; SZ 4437
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6107428552
• MDR Report Key: 13087473
• MDR Text Key: 288200603
• Report Number: 8030965-2021-10466
• Device Sequence Number: 1
• Product Code: GEY
• UDI-Device Identifier: 07611819138667
• UDI-Public: 07611819138667
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 530.730
• Device Lot Number: 8745392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2014
• 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