MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE OMEGA 3.9MM PEEK KNOTLESS ANCHOR SYSTEM, SINGLE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-500-391
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for investigation therefore the reported failure mode was not confirmed.Alleged failure: the eyelet both broke, and pulled out of the bone through the cortex.Probable root cause: design.Inadequate (b)(4) 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 failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the product broke.Per additional information received, the product cracked but no broken pieces separated from the it.The procedure was completed successfully.

• Brand Name: OMEGA 3.9MM 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
• MDR Report Key: 8396924
• Report Number: 0002936485-2019-00091
• Device Sequence Number: 390050
• Product Code: MBI
• UDI-Device Identifier: 37613327464796
• UDI-Public: 37613327464796
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K181083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2019

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: 3910-500-391
• Device Lot Number: 18353AG2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 03/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR