MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE REELX STT 4.5MM KNOTLESS ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-600-062
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the reelx was loaded with four #2 suture ends and inserted directly into the soft bone and fixed with at least one turn.The operation was completed.The subsequent x-ray examination showed that the anchor had become detached from the bone.A revision surgery was performed.The anchor was removed from the joint using grasping forceps; one half of the anchor had flaked off.The refixation was renewed with a different anchor system.
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: anchor pullout.Probable root cause: design: - anchor geometry insufficient to maintain fixation during healing - insufficient material strength.Application: - poor patient compliance during healing - too much tension applied to anchor - poor bone quality - pilot hole preparation with incorrect instrumentation - use of less than 2 suture tails or more than 4 suture tails - use of suture not indicated for reelx the reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the reelx was loaded with four #2 suture ends and inserted directly into the soft bone and fixed with at least one turn.The operation was completed.The subsequent x-ray examination showed that the anchor had become detached from the bone.A revision surgery was performed.The anchor was removed from the joint using grasping forceps; one half of the anchor had flaked off.The refixation was renewed with a different anchor system.

• Brand Name: REELX STT 4.5MM KNOTLESS ANCHOR
• 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: 19238578
• Report Number: 0002936485-2024-00364
• Device Sequence Number: 8072230
• Product Code: MBI
• UDI-Device Identifier: 37613252592809
• UDI-Public: 37613252592809
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K120824
• 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,Followup
• Report Date (Section B): 07/09/2024

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: 3910-600-062
• Device Lot Number: 23123AG2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/09/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/03/2023
• 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