MAUDE Adverse Event Report: SYNTHES GMBH CHUCK W/KEY F/COMPACT AIR DRIVE+POWER DR; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number 511.730

Device Problem Compatibility Problem (2960)

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

Event Date 01/01/2021

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up 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 damages/breaks the k-wire device.Therefore, the reported condition was confirmed.The assignable root cause of this condition was determined to be traced to maintenance, which is user error/misuse/abuse.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 damages/breaks the k-wire device, the coupling could not engage the attachment device, and there was component damage.It was further determined that the device failed pretest for check handpiece coupling, and check clamping range of 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 W/KEY F/COMPACT AIR DRIVE+POWER DR
• 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: 11614638
• MDR Text Key: 243938194
• Report Number: 8030965-2021-02472
• Device Sequence Number: 1
• Product Code: HWE
• UDI-Device Identifier: 07611819036420
• UDI-Public: 7611819036420
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 511.730
• Device Lot Number: 1037919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Date Manufacturer Received: 03/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/1999
• 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