MAUDE Adverse Event Report: SYNTHES GMBH SAW BLADE 10 WIDTH 25/0.6 CUT THICKNESS; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	532.062
Medical Device Problem Codes	Dull, Blunt (2407); Separation Problem (4043)
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 this medwatch, a supplemental medwatch report will be filed as appropriate.Concomitant med products and therapy dates: sagittal saw attachment.The manufacturing site name is currently not available.Device history record review: a device history review was performed and no non-conformance's were identified related to the reported condition.Device evaluation: the actual device was returned for evaluation.During repair, an evaluation was performed, and it was determined that the initial reported condition of the device not working anymore was not confirmed.Therefore, an assignable root cause was not determined.However, the reported condition of the worn cutting teeth identified during service and evaluation was confirmed.It was determined that the most probable cause for the found defect was due to normal wear over time, and the dents detected could be linked to user error.The assignable root cause of the dull cutter was determined to be due to component failure from normal wear.Udi: (b)(4).
Event or Problem Description
It was reported by (b)(6) that during service and evaluation, it was determined that the saw blade device was stuck inside the sagittal saw attachment device when it was received.It was further determined that the saw blade was able to be removed from the sagittal saw attachment.It was further determined that the cutting teeth were severely worn, and the saw blade showed dents from the removal and a lateral ridge which most likely was caused by the interaction with a cutting block during usage.It was further observed that the device failed visual inspection.It was noted in the service order that the sagittal saw attachment device did not work anymore while being used together with the saw blade device.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 unknown.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

• Brand Name: SAW BLADE 10 WIDTH 25/0.6 CUT THICKNESS
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12276052
• Report Number: 8030965-2021-06412
• Device Sequence Number: 20108018
• Product Code: GFA
• UDI-Device Identifier: 07611819097490
• UDI-Public: 07611819097490
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/28/2021

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: 532.062
• Device Lot Number: 2L93113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1