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

Catalog Number	3910-600-060
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2018
Type of Reportable Event	Malfunction
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 the tip of the product broke.All pieces were retrieved and the procedure was completed successfully.
Additional Manufacturer Narrative
Alleged failure: during preparation of the anchor the distal metal tip of the reelx shoulder anchor broke.The metal tip has been removed and the surgery completed by using another anchor.The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: hard bone, excessive force applied on device, incorrect angle of attack (too steep/shallow), no pilot hole prepared in the event of hard bone, or incorrect instrumentation used to prepare pilot hole.The device manufacture date is not known.The product was returned for investigation and the failure mode was confirmed and will be monitored for future reoccurrence.
Event or Problem Description
It was reported that the tip of the product broke.All pieces were retrieved and the procedure was completed successfully.

• Brand Name: REELX STT 5.5MM ANCHOR, PEEK/SS KNOTLESS (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: 7639930
• Report Number: 0002936485-2018-00511
• Device Sequence Number: 1898923
• Product Code: MBI
• UDI-Device Identifier: 37613252017579
• UDI-Public: 37613252017579
• Combination Product (Y/N): N
• PMA/510(K) Number: K090530
• 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): 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 3910-600-060
• Device Lot Number: 74L1702850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2018
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 06/26/2018
• Supplement Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1