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

Catalog Number	3910-500-472
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
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: eyelet broke during procedure.Probable root cause: design eyelet/inserter interface not designed to maintain proper assembly process; eyelet or inserter not manufactured to specification application; user manipulates pull tab improperly; user does not exercise care for assembly during handling; user attempts to fully seat eyelet.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the eyelet broke during the procedure.The proximal fragment was removed and the distal fragment was secured underneath the replacement anchor.

• Brand Name: OMEGA 4.75MM PEEK KNOTLESS ANCHOR SYSTEM, DOUBLE-DOUBLE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 8335449
• Report Number: 0002936485-2019-00062
• Device Sequence Number: 1959744
• Product Code: MBI
• UDI-Device Identifier: 37613327464833
• UDI-Public: 37613327464833
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/13/2019

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: 3910-500-472
• Device Lot Number: 18353AG2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 02/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 83