MAUDE Adverse Event Report: TORNIER INC AEQ. RETRACTOR SHOULDER SYSTEM

Catalog Number	9000381
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the plastic darrach retractor broke during shoulder replacement operation.Surgeon was attempting to dislocate shoulder, and the retractor broke in two pieces.
Additional Manufacturer Narrative
Correction: h6 health impact code.The reported event was confirmed since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the returned device is clearly broken at the distal end.The breakage area exhibits signs of static failure with evidence of plastic deformations and strain at the breakage point.This is followed by signs of instantaneous brittle fracture evidenced by the smooth, shiny appearance at the breakage point.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design-related problems were found during the investigation.Based on investigation, the root cause was attributed to a combination of typical wear and use.The failure was caused by normal and frequent usage.The device is used to move and hold typically tense soft tissue so the surgeon can access glenohumeral joint.Over time, the combination of pressure exerted on the device and multiple cleaning/sterilization cycles, can result in the weaking of the material resulting in the event noted in this complaint.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
It was reported that the plastic darrach retractor broke during shoulder replacement operation.Surgeon was attempting to dislocate shoulder, and the retractor broke in two pieces.

• Brand Name: AEQ. RETRACTOR SHOULDER SYSTEM
• Common Device Name: RETRACTOR
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22153118
• Report Number: 0001649390-2025-00381
• Device Sequence Number: 9199786
• Product Code: GAD
• UDI-Device Identifier: 00846832021963
• UDI-Public: (01)00846832021963(11)221004(10)BFA25EO
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2025

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 Catalogue Number: 9000381
• Device Lot Number: BFA25E0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 06/05/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2025
• 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 Sex: Unknown