MAUDE Adverse Event Report: SYNTHES GMBH CHUCK-KEYLESS F/BPL; SURGICAL DRILL CHUCK

Catalog Number	530.731
Medical Device Problem Codes	Mechanical Jam (2983); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during service and evaluation, it was determined that the chuck attachment device was frozen/will not move - chuck seized, had illegible etching, and component damage.It was further determined that the device failed pretest for general condition, markings, and check drill chuck function.It was noted in the service order that the device was tagged "out of service".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.
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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: the actual device was returned for evaluation.The device was evaluated and it was determined that the reported condition was confirmed.The assignable root cause was traced to improper maintenance.Udi: (b)(4).
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.During repair, an evaluation was performed and it was determined that the keyless chuck device was frozen/will not move, the etching was illegible, and had component damage.It was further determined that the device failed pretest for general condition, markings, and check drill function.Therefore, the reported condition was confirmed.The assignable root cause of this condition was determined to be traced to maintenance, which is improper maintenance.Correction: d9: the date returned to manufacturer was documented as january 4, 2024 on the initial report.This date has been updated to january 3, 2024.

• Brand Name: CHUCK-KEYLESS F/BPL
• Common Device Name: SURGICAL DRILL CHUCK
• 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: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 18723154
• Report Number: 8030965-2024-02601
• Device Sequence Number: 5586936
• Product Code: GEY
• UDI-Device Identifier: 10886982240163
• UDI-Public: 10886982240163
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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: 530.731
• Device Lot Number: 3249583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Supplement Date Received by Manufacturer: 03/05/2024; 05/15/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 03/13/2024; 05/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2011
• 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