MAUDE Adverse Event Report: OMEGA SURGICAL INSTRUMENTS SM-4011M; ORTHOPEDIC SAW BLADE

Model Number	SM-4011M
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	02/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during podiatric surgery, a small portion of blade teeth broke off into the 3rd curniform while the surgeon was making cuts with the zero degree adductoplasty cut guide.The broken portion could not be removed from patient.Surgeon indicated that either the blade made contact with a short pin fixation and broke off or the blade became too hot and broke off.A backup device was available for use and the surgery was completed without adverse delay.The breakage did not prevent successful completion of surgery.No irreversible impairment or damage to patient.Device was not returned to manufacturer.Investigation could not be completed regarding cause of breakage and no conclusion drawn.Inspection of quality documents demonstrate no deviation of material certificates or device specifications.Device was used for treatment, not diagnosis.If additional information is made available, the investigation will be updated as applicable.
Additional Manufacturer Narrative
Device was not returned to manufacturer.Investigation could not be completed regarding cause of breakage and no conclusion drawn.Inspection of quality documents demonstrate no deviation of material certificates or device specifications.Device was used for treatment, not diagnosis.If additional information is made available, the investigation will be updated as applicable.

• Brand Name: SM-4011M
• Common Device Name: ORTHOPEDIC SAW BLADE
• Manufacturer (Section D): OMEGA SURGICAL INSTRUMENTS; 1072 s. elms road; suite e; flint 48532
• Manufacturer (Section G): OMEGA SURGICAL INSTRUMENTS; 1072 s. elms rd.; suite e; flint MI 48532
• Manufacturer Contact: kari burba ; 1072 s. elms rd; suite e; flint, MI 48532 ; 8106959800
• MDR Report Key: 14526681
• Report Number: 1834251-2022-00001
• Device Sequence Number: 14650950
• Product Code: GFA
• UDI-Device Identifier: 00817438027673
• UDI-Public: 00817438027673
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/10/2022

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: SM-4011M
• Device Catalogue Number: SM-4011M
• Device Lot Number: 19041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown