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	Burn(s) (1757)
Date of Event	09/23/2025
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 the initial medwatch, a follow-up medwatch will be filed as appropriate.H.11.Additional narrative: d4, h4: the device serial/lot number, complete udi and date of manufacture are unknown at this time.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
This is report 1 of 2 for the same event.It was reported that during a mandibular bilateral sagittal split osteotomy procedure, the saw attachment device and pen drive device were being used when the patient had received burns on their lip due to the end attachment of the pen drive device becoming extremely hot with use and burning the patient.No known injuries were reported other than extended recovery and increased risk of infection.No reports of any medical intervention or delays in the procedure.All available information has been disclosed at this time.
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 the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: additional information was received reporting that the burn that the patient received was superficial and will take a couple of weeks to heal.No additional medical or surgical interventions were reported.
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 the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: a visual and functional assessment was performed: the following steps failed: check function of release sleeve check tool/saw blade coupling check alignment of tool- to handpiece coupling check general function in running mode check oscillation frequency with frequency meter.During service/repair the following was observed: attachment release sleeve jammed and rough turning.Replaced lift rod with connecting rod cpl and full service done.Attachment tested working within specification.During the service evaluation the following failures were identified: functional: jammed/seized functional: noise - excessive.Conclusion: failure reported is not confirmed root cause: component wear action: repair.

• 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: kate karberg ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 3035526892
• MDR Report Key: 23253287
• Report Number: 8030965-2025-10009
• Device Sequence Number: 10254203
• Product Code: ERL
• UDI-Device Identifier: 07611819167902
• UDI-Public: (01)07611819167902(10)5L18794
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/06/2025

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: 5L18794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 10/14/2025; 01/08/2026
• Initial Report FDA Received Date: 10/09/2025
• Supplement Report FDA Received Date: 10/15/2025; 01/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2019
• 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 Age: 16 YR
• Patient Sex: Male