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	04/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
Event or Problem Description
It was reported that after implantation of the anchor, some fracture piece were noticed in area of peek end.The piece was removed.During attempts to tension the thread, after one turn it was not possible to continue, there was no possibility to tighten.It was necessary to cut the threads.The anchor was left, as it was properly set but it was not functional.There was a 30 minute delay.The implant remained in the shoulder bone, which may require additional surgery or treatment.
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 fragmented probable root cause: design.Nsufficient material strengh.Anchor assembly design not strong enough to withstand impaction.Anchor geometry too blunt for effective bone penetration.Application hard bone.Excessive force incorrect angle of attack (too steep/shallow).No pilot hole prepared in the event of hard bone.Incorrect instrumentation used to prepare pilot hole.The reported failure mode will be monitored for future reoccurrence.
Event or Problem Description
It was reported that after implantation of the anchor, some fracture piece were noticed in area of peek end.The piece was removed.During attempts to tension the thread, after one turn it was not possible to continue, there was no possibility to tighten.It was necessary to cut the threads.The anchor was left, as it was properly set but it was not functional.There was a 30 minute delay.The implant remained in the shoulder bone, which may require additional surgery or treatment.

• 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: 19238569
• Report Number: 0002936485-2024-00363
• Device Sequence Number: 20845395
• Product Code: MBI
• UDI-Device Identifier: 37613252592809
• UDI-Public: 37613252592809
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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: 3910-600-062
• Device Lot Number: 23158AG2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2024
• Supplement Date Received by Manufacturer: 04/06/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/07/2023
• 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