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	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2021
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 the tip of the anchor broke during the procedure and pieces remained in the patient.
Event or Problem Description
It was reported that the tip of the anchor broke during the procedure and pieces remained in the patient.
Additional Manufacturer Narrative
Alleged failure: the customer reported that : "during procedure, the tip of the anchor gave way." the failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) hard bone, 2) use of excessive force, 3) incorrect angle of attack (too steep/shallow), 4) no pilot hole prepared in the event of hard bone, or 5) incorrect instrumentation used to prepare pilot hole.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.

• 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: 11318204
• Report Number: 0002936485-2021-00087
• Device Sequence Number: 11793684
• Product Code: MBI
• UDI-Device Identifier: 37613252017579
• UDI-Public: 37613252017579
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2021

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
• Device Lot Number: 74A2000769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 04/27/2021
• 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