MAUDE Adverse Event Report: SYNTHES GMBH RECIPROCATING SAW ATCH FOR PEN DRIVE; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	05.001.040
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
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: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
It was reported that the drill attachment and the reciprocating saw attachment were heating up.It was not reported if the device was used in a surgical procedure.There was no delay reported.It was reported that there were no 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.This is report 1 of 2 for (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: device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed and the reported condition that the attachment device was overheating was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation it was determined that the device had a seized bearing.It was noted that the attachment seized up due to bearings being faulty.It was further determined that the device failed pretest for check general function in running mode and check oscillation frequency with frequency meter the value of frequency meter.The assignable root cause of this condition was determined to be traced to component failure due to wear.

• Brand Name: RECIPROCATING SAW ATCH FOR PEN DRIVE
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: elba bello ; eimattstrasse 3; oberdorf 04436 ; SZ 04436 ; 9083863534
• MDR Report Key: 23822315
• Report Number: 8030965-2025-12655
• Device Sequence Number: 15777861
• Product Code: ERL
• UDI-Device Identifier: 07611819167902
• UDI-Public: (01)07611819167902(10)6L92393
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K043310
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,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: 05.001.040
• Device Lot Number: 6L92393
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2025
• Supplement Date Received by Manufacturer: 12/26/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2020
• 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