MAUDE Adverse Event Report: SYNTHES GMBH LARGE CHUCK WITH KEY DRILLING SPEED; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT

Catalog Number	05.001.253
Medical Device Problem Codes	Device Slipped (1584); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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: the actual device was returned for evaluation.Quality engineering evaluated the chuck with key device and the reported condition that there was an abnormal separation in the attachment itself was confirmed.An assessment was performed, and it was found that the device failed visual inspection.During the assessment of the device and the provided photo it was found that the drill chuck was separating from the stop ring and the locking mechanism of the device was stuck.It was further determined that the device failed pre-test for general condition, check drill chuck function, check drill chuck in smallest range, and check drill chuck in largest range.The assignable root cause of this condition was determined to be traced to component failure due to wear.Udi - (b)(4).
Event or Problem Description
It was reported that there was an abnormal separation in the large chuck with key device itself.During in-house engineering evaluation it was determined that the drill chuck is separating from the stop ring.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.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: LARGE CHUCK WITH KEY DRILLING SPEED
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED, MOTOR/ACCESS AND ATTACHMENT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 18383211
• Report Number: 8030965-2023-16067
• Device Sequence Number: 15405523
• Product Code: HWE
• UDI-Device Identifier: 07611819979734
• UDI-Public: 07611819979734
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 05.001.253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown