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

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/02/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 298607112
• Report Number: 0002936485-2022-00485
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 37613327464796
• UDI-Public: 37613327464796
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K181083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR
• Patient Sex: Male