MAUDE Adverse Event Report: STERILMED, INC. SAW BLADE SAGITTAL DUAL CUT; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	STR4135-089-064
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.As such, the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.Since no lot number was provided, no manufacturing record evaluation review could be performed.Date of event, exact date is unknown, however this occurred in (b)(6) 2019.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).
Event or Problem Description
It was reported that a (b)(6), female patient underwent a total knee revision with a reprocessed saw blade sagittal dual cut and the reciprocating saw blade broke during the procedure.
Additional Manufacturer Narrative
Additional information was received on january 8, 2020.The device was a new device and not a sterilmed reprocessed device.A stryker handpiece was used.The tip portion of the blade broke.There was no difficulty noticed before the device broke.There were no specific procedural or patient circumstance that contributed to the break.Replacement device of the same type was used to complete the procedure successfully.There was no patient injury or patient consequence.Per the additional information received, this device is not a sterilmed device therefore this event is not mdr reportable.Manufacturer's ref.No: (b)(4).

• Brand Name: SAW BLADE SAGITTAL DUAL CUT
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 9569527
• Report Number: 2134070-2020-00001
• Device Sequence Number: 10872228
• Product Code: GFA
• UDI-Device Identifier: 10888551030755
• UDI-Public: 10888551030755
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2019

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: STR4135-089-064
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 01/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 81