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	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tunnel was made with the drill bit and its guide, then the anchor was entered into the previously made hole, it proceeded to impact up to the guide line and when it was in the middle, it fractured in the body.The pieces were potentially not able to be retrieved.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that the anchor broke.No pieces were separated.
Additional Manufacturer Narrative
Alleged failure: the respective tunnel was made with the 4.5mm drill bit and its guide, then the 4.5 reelx anchor was entered into the previously made hole, then it proceeded to impact up to the guideline and when it was in the middle, it fractured in the body.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) use of excessive force, 2) hard bone, 3) incorrect angle of attack (too steep/shallow), 4) no pilot hole prepared in the event of hard bone, 5) incorrect instrumentation used to prepare pilot hole.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

• 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: 19098010
• Report Number: 0002936485-2024-00328
• Device Sequence Number: 7705456
• Product Code: MBI
• UDI-Device Identifier: 37613252592809
• UDI-Public: 37613252592809
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K120824
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

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: 23122AG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 11/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• 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: Male
• Patient Weight: 70 KG