MAUDE Adverse Event Report: TELEFLEX MEDICAL STRYKER REELX STT 5.5MM ANCHOR; FASTENER, FIXATION, NONDEGRAD

Model Number	3910-600-060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).No issues or discrepancies were found in the device history record of product code 3910-600-060/batch 74a2000769 that can be related to the failure mode reported by the customer.As part of this investigation the sterilization department and the nadc department were reached out, no damages were reported from the sterilizer nor the distribution center for the lot in question.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
We recently received a pkg.Reelx stt 5.5mm knotless suture anchor as a complaint.The reported complaint states: during procedure, the tip of the anchor gave way.There was no delay for the patient and no additional intervention.The tip of the anchor broke but the fragments were not recovered.The procedure was completed without a hitch after changing the equipment.

• Brand Name: STRYKER REELX STT 5.5MM ANCHOR
• Common Device Name: FASTENER, FIXATION, NONDEGRAD
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11655781
• Report Number: 3004365956-2021-00157
• Device Sequence Number: 3520423
• Product Code: MBI
• UDI-Device Identifier: 07613252017578
• UDI-Public: 07613252017578
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/07/2021

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 Expiration Date: 01/06/2022
• Device Model Number: 3910-600-060
• Device Catalogue Number: 3910-600-060
• Device Lot Number: 74A2000769
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1