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 Code	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 device.The lot number was unknown; therefore, the device manufacture date is unknown, and the udi is incomplete.The manufacturing site name is currently not available.Device history record review: it was determined that due to the severe scratches on the saw blade surface, it was not possible to read the product identification or lot number, therefore the device history record review could not be performed.Device evaluation: the actual device was returned for evaluation.Quality engineering evaluated the device and determined that the reported condition of the device being stuck was not confirmed.Therefore, an assignable root cause was not determined.However, the reported condition of the worn teeth was confirmed.It was determined that the cause of the damaged saw and the illegible labeling was due to improper handling by the user, and the worn teeth was due to normal wear.The assignable root cause 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 jammed inside the sagittal saw attachment device and was able to be released from the attachment.It was further determined that there were severe scratches on the saw blade surface which made it impossible to read the product identification or lot number.It was observed that the saw blade was bent, the cutting teeth showed signs of heavy wear, and the surface was heavily scratched off.It was further determined that the device failed visual inspection.It was noted in the service order that during pre-surgery, it was discovered that the sagittal saw attachment device did not work anymore and the saw blade device was stuck.It was not reported if there were any delays in the surgical procedure or if a spare device was available for use.There was no patient involvement reported.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 report 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: 12127618
• Report Number: 8030965-2021-05564
• Device Sequence Number: 4723193
• 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): 06/14/2021

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2021
• Initial Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1