MAUDE Adverse Event Report: SYNTHES GMBH SAW BLADE 27 WIDTH 70/0.8 CUT THICKNESS; BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL

Catalog Number	519.170
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The actual device was returned for evaluation.  quality engineering evaluated the device and it was determined that the reported condition was confirmed.The assignable root cause was determined to be linked to a user error as the bend tooth most likely resulted from lateral forces which also tightened the clamping mechanism so the saw blade could not get removed at customer site.The other findings were linked to component damage from normal wear.A device history review was performed, and no non-conformances were detected related to the reported condition.Udi: (b)(4).
Event or Problem Description
It was reported from (b)(6) that during service and evaluation, it was determined that the cutter device showed signs of heavy usage and one tooth was heavily bent, three more teeth showed heavy wear and were dull.It was noted in the service order that the device did not work properly at all.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The date of event was unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: SAW BLADE 27 WIDTH 70/0.8 CUT THICKNESS
• Common Device Name: BLADE, SAW, GENERAL AND PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11992839
• Report Number: 8030965-2021-04607
• Device Sequence Number: 923389
• Product Code: GFA
• UDI-Device Identifier: 07611819037120
• UDI-Public: 07611819037120
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K971544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/04/2021

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: 519.170
• Device Lot Number: 6L66668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1