MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG., AGG. PLUS SHAVER BLADE, SMALL JOINT, F - SERIES - 3.5MM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	0375638000
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the device broke during the procedure and a piece was left in the patient.The patient needed to be brought back to surgery for retrieval.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: shaver piece broke off.Probable root cause: inadequate window profile, inadequate welding process, improper material strength, inadequate size selected for the application, material brittleness , excessive force applied by the user, incorrect rfid tag.The failure mode will be monitored for future reoccurrence.H3 other text : 81.
Event or Problem Description
It was reported that the device broke during the procedure and a piece was left in the patient.The patient needed to be brought back to surgery for retrieval.

• Brand Name: PKG., AGG. PLUS SHAVER BLADE, SMALL JOINT, F - SERIES - 3.5MM
• 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: 14634619
• Report Number: 0002936485-2022-00303
• Device Sequence Number: 5157168
• Product Code: GFA
• UDI-Device Identifier: 37613327061995
• UDI-Public: 37613327061995
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2022

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: 0375638000
• Device Lot Number: 19043CE2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/11/2022
• Supplement Date Received by Manufacturer: 05/11/2022
• Initial Report FDA Received Date: 06/08/2022
• Supplement Report FDA Received Date: 08/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2019
• 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 Sex: Unknown