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 Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the reelx was loaded with four #2 suture ends and driven directly into the soft bone.A rotation of the black knob was performed, the rotation could be performed with little resistance, a sudden cancellation of the resistance was not felt.The inserter was released.During arthroscopic examination of the anchor, the surgeon noticed that it was coming out of the bone again.The anchor was pulled out again with grasping forceps, one half of the anchor had flaked off.The chipped part could not be found.In order to remove the anchor from the joint, the sutures were cut and the anchor body removed.The operation was continued with a different anchor system and the refixation was renewed.
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.
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: insufficient 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 the reelx was loaded with four #2 suture ends and driven directly into the soft bone.A rotation of the black knob was performed, the rotation could be performed with little resistance, a sudden cancellation of the resistance was not felt.The inserter was released.During arthroscopic examination of the anchor, the surgeon noticed that it was coming out of the bone again.The anchor was pulled out again with grasping forceps, one half of the anchor had flaked off.The chipped part could not be found.In order to remove the anchor from the joint, the sutures were cut and the anchor body removed.The operation was continued with a different anchor system and the refixation was renewed.
Additional Manufacturer Narrative
The investigation was previously closed based on product not received; however, the product has now been physically received at stryker endoscopy, usa and the investigation has been re-opened.Investigation as follows is now based on product received.Alleged failure: reelx was loaded with four #2 suture ends and driven directly into the soft bone.A rotation of the black knob was performed, the rotation could be performed with little resistance, a sudden cancellation of the resistance was not felt.The inserter was released.During arthroscopic examination of the anchor, the surgeon noticed that it was coming out of the bone again.The anchor was pulled out again with grasping forceps, one half of the anchor had flaked off.The chipped part could not be found.In order to remove the anchor from the joint, the sutures were cut and the anchor body removed.The operation was continued with a different anchor system and the refixation was renewed.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.
Event or Problem Description
It was reported that the reelx was loaded with four #2 suture ends and driven directly into the soft bone.A rotation of the black knob was performed, the rotation could be performed with little resistance, a sudden cancellation of the resistance was not felt.The inserter was released.During arthroscopic examination of the anchor, the surgeon noticed that it was coming out of the bone again.The anchor was pulled out again with grasping forceps, one half of the anchor had flaked off.The chipped part could not be found.In order to remove the anchor from the joint, the sutures were cut and the anchor body removed.The operation was continued with a different anchor system and the refixation was renewed.

• 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: 19238577
• Report Number: 0002936485-2024-00365
• Device Sequence Number: 8072229
• 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,Followup
• Report Date (Section B): 06/12/2025

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: 23237AG2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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; 05/18/2025
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 07/09/2024; 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2023
• 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