MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE OMEGA 4.75MM PEEK KNOTLESS ANCHOR SYSTEM, SINGLE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-500-471
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2021
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 eyelet breakage occurred in the joint and all pieces were retrieved.
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: omega eyelet broken in pieces probable root cause: design - inadequate raw material selection for eyelet anchor - design geometry too sensitive to withstand clinical impaction loads - eyelet/inserter interface not designed to maintain proper assembly process - eyelet anchor or inserter shaft not manufactured to specification - incorrect material used during manufacturing - eyelet anchor and inserter not assembled to specification application - excessive force or leveraging of the anchor against the bone - user fully seats eyelet anchor onto inserter which eliminates interference fit - inadequate assessment of bone quality, pilot hole not prepared the reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the eyelet breakage occurred in the joint and all pieces were retrieved.

• Brand Name: OMEGA 4.75MM PEEK KNOTLESS ANCHOR SYSTEM, SINGLE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• 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: 15879584
• Report Number: 0002936485-2022-00702
• Device Sequence Number: 14802260
• Product Code: MBI
• UDI-Device Identifier: 37613327464819
• UDI-Public: 37613327464819
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K181083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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 Catalogue Number: 3910-500-471
• Device Lot Number: 21224AG2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/29/2021
• Supplement Date Received by Manufacturer: 12/29/2021
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2021
• 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
• Patient Age: 75 YR
• Patient Sex: Male