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 Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Alleged failure: in a slap lesion shoulder, the guide tip bent 90 degrees when the eyelet was driven in, despite pre-drilling with omega awl.This occurred with two products during the same surgery.Replacement was available.Visual inspection: the inserter tip was bent and the anchor was broken.The anchor piece was not returned.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) user handling error, 2) user does not exercise care with assembly (i.E.Forces device during insertion resistance).The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
Event or Problem Description
The device was returned for investigation with a broken anchor and the broken piece was not returned.Multiple attempts were made to gather additional information, however no information was received.Therefore this is being filed for the anchor potentially breaking during the procedure and potentially remaining 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: andrea zenere ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 15294668
• Report Number: 0002936485-2022-00485
• Device Sequence Number: 12321410
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2022

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: 3910-500-391
• Device Lot Number: 21294AG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2022
• Initial Report FDA Received Date: 08/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 YR
• Patient Sex: Male