MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG. REELX STT 5.5MM KNOTLESS SUTURE ANCHOR(BOX OF 5); FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	3910-600-060
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
Event or Problem Description
It was reported that there was a need for a revision surgery.
Event or Problem Description
It was reported that there was a need for a revision surgery.
Additional Manufacturer Narrative
Alleged failure: the anchors slipped out despite professional implantation in the humeral head.The probable root causes could be: 1) excessive force during tensioning, 2) too much initial tension in suture, or 3) soft bone results in anchor pullout during tensioning, bone cannot retain anchor to withstand tensioning forces.The product was returned for investigation and the reported failure mode was confirmed.The failure mode will be monitored for future reoccurrence.Lot number is unknown; therefore, manufacture date can not be confirmed.

• Brand Name: PKG. REELX STT 5.5MM KNOTLESS SUTURE ANCHOR(BOX OF 5)
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• MDR Report Key: 11498045
• Report Number: 0002936485-2021-00152
• Device Sequence Number: 11480563
• Product Code: MBI
• UDI-Device Identifier: 37613252017579
• UDI-Public: 37613252017579
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K090530
• 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): 04/19/2021

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: 3910-600-060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Received by Manufacturer: 02/15/2021
• Supplement Date Received by Manufacturer: 02/15/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other