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

Model Number	3910-600-060
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2021
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 74b2001733 that can be related to the failure mode reported by the customer.
Event or Problem Description
We recently received three (3) pkg.Reelx stt 5.5mm knotless suture anchor as complaints.The reported complaint states: the anchors slipped out despite professional implantation in the humeral head.The three anchors had pulled out.Damage was noted on the anchors.The patient will need a revision surgery.Date of the revision is unknown.Healing time significantly prolonged.

• Brand Name: STRYKER REELX STT 5.5MM ANCHOR
• Common Device Name: FASTENER, FIXATION, NONDEGRAD
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11585431
• Report Number: 3004365956-2021-00126
• Device Sequence Number: 3291716
• 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): 03/15/2021

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: 02/19/2022
• Device Model Number: 3910-600-060
• Device Catalogue Number: 3910-600-060
• Device Lot Number: 74B2001733
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 03/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1