MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS, INC. FIN-LOCK SIZER. L; TEMPLATE

Model Number	SZR-0926-030-030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during surgery, the attachment rub of the fin-lock sizer.L broke off.No pieces fell inside of the patient.It is unknown how the surgery was completed.No delay was reported.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).This complaint was originally created in the integra lifesciences complaint management system.This complaint is being migrated into smartsolve as complaint handling for this product has transferred from integra to smith+nephew.As such, some details in the complaint record may represent legacy integra complaint handling processes.Evaluation of the returned device found that the center peg of the sizer was broken off and missing.Examination of the device verified that the most probable cause for the failure was wear and damage due to normal use.The fin-lock sizer is a reusable instrument expected to be used across multiple surgeries.The instrument is made of polysulfone, a type of plastic.The sizer is held by the angled handle; when the sizer is in the appropriate position on the glenoid, a guide wire is inserted into the bone through a cannula in the angled handle and the peg of the sizer.This action may subject the peg of the fin-lock sizer to significant force.Therefore, the plastic peg of the sizer may fail after prolonged use or if subjected to excessive force.

• Brand Name: FIN-LOCK SIZER. L
• Common Device Name: TEMPLATE
• Manufacturer (Section D): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS, INC.; 11101 metric blvd; austin TX 78758
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15669990
• Report Number: 3002788818-2022-00070
• Device Sequence Number: 6421397
• Product Code: HWT
• UDI-Device Identifier: 10381780258599
• UDI-Public: 10381780258599
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/25/2022

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 Model Number: SZR-0926-030-030
• Device Catalogue Number: SZR-0926-030-030
• Device Lot Number: 20347708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2022
• Initial Report FDA Received Date: 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Male