MAUDE Adverse Event Report: SYNTHES GMBH RECIP SAW BLADE DBL-SIDED 68MM X 0.80MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Model Number	511.914S
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.The device serial or lot number was unknown; therefore, udi: (b)(4).The manufacturing location is unknown.Device manufacture date is unknown.The device serial or lot number is unknown.
Event or Problem Description
It was reported that during a total knee arthroplasty surgical procedure, it was observed that the rhombus part of the saw blade device had broken.It was reported that there was a more than 30 minute delay in the procedure.It was not reported whether a spare device was available for use.It was reported that the postoperative x-ray indicated that there were no fragments in the patient's body.The surgeon predicted that the fragments would be expelled by the body through "inhalation".There was patient involvement.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.

• Brand Name: RECIP SAW BLADE DBL-SIDED 68MM X 0.80MM
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6107428552
• MDR Report Key: 12846149
• Report Number: 8030965-2021-09656
• Device Sequence Number: 17295353
• Product Code: GFA
• UDI-Device Identifier: 10886982238221
• UDI-Public: 10886982238221
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2020

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 Model Number: 511.914S
• Device Catalogue Number: 511.914S
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2020
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown