MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., BARREL BUR, 6 FLUTE F - SERIES - 4.0MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0375941000
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Muscle/Tendon Damage (4532); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the device broke leading to an injury to the muscle of the patient.
Event or Problem Description
It was reported that the device broke leading to an injury to the muscle of the patient.
Additional Manufacturer Narrative
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: incised injury probable root cause: excessive force applied by user; inadequate window profile; excessive vibration; surgeons setting above the recommended settings; incorrect rfid tag; incorrect diamond grit size/ type.Inadequate coating process.The reported failure mode will be monitored for future recurrence.H3 other text: 81.

• Brand Name: PKG., BARREL BUR, 6 FLUTE F - SERIES - 4.0MM
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15496270
• Report Number: 0002936485-2022-00542
• Device Sequence Number: 5070102
• Product Code: GFA
• UDI-Device Identifier: 37613327054744
• UDI-Public: 37613327054744
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0375941000
• Device Lot Number: 21155CE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2021
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Male