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	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2023
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 inserter broke during procedure and was potentially unable to the retrieved from patient.
Additional Manufacturer Narrative
Alleged failure: md popescu andrei from zetta clinic -bucharest, reported to stryker sales rep.That the reelx 5.5 anchor system broke during the medical intervention (surgery).The failure(s) identified in the investigation is consistent with the complaint record.The probable root causes could be: 1) use excessive force, 2) hard bone.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.Manufacture date is not known.
Event or Problem Description
It was reported that the anchor broke during procedure and was potentially unable to the retrieved from patient.

• 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
• 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: 16342553
• Report Number: 0002936485-2023-00110
• Device Sequence Number: 6882152
• Product Code: MBI
• UDI-Device Identifier: 37613252017579
• UDI-Public: 37613252017579
• Combination Product (Y/N): N
• Initial Reporter Country: RO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2023

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: 74G2102298
• 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: 01/13/2023
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 02/09/2023
• Supplement Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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