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
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the eyelets broke.The eyelet came out again on one, the eyelet broke on the other and only the thread came out.The broken pieces potentially remained in the patient.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Additional Manufacturer Narrative
Alleged failure: the eyelets broke, the thread didn't hold.The eyelet came out again on one, the eyelet broke on the other and only the thread came out.Replacement was available.The failure alleged in the complaint record was not confirmed/duplicated during the product investigation.The probable root causes could be: 1) excessive force or leveraging of the anchor against the bone, 2) user fully seats eyelet anchor onto inserter which eliminates interference fit, 3) inadequate assessment of bone quality, pilot hole not prepared.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the eyelets broke.The eyelet came out again on one, the eyelet broke on the other and only the thread came out.The broken pieces potentially remained in the patient.

• 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
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: lucas wolski ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 18360645
• Report Number: 0002936485-2023-01279
• Device Sequence Number: 7697445
• Product Code: MBI
• UDI-Device Identifier: 37613327464796
• UDI-Public: 37613327464796
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K181083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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: 3910-500-391
• Device Lot Number: 22290AG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/27/2023
• Supplement Date Received by Manufacturer: 11/27/2023
• Initial Report FDA Received Date: 12/19/2023
• Supplement Report FDA Received Date: 05/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• 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