MAUDE Adverse Event Report: TORNIER S.A.S. ASC FLEX CENTERED REVERS PLATFORM TRIAL D40 TH 0 EXC 0 STD; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number	MWF500S
Medical Device Problem Codes	Degraded (1153); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the scrub tech had accidentally contaminated the screwdriver used to remove the tray from the trial stem and the surgeon attempted to remove it without the screw being fully backed out.That caused the screw to strip through the surrounding plastic threading.This caused almost no delay in the procedure and the patient did not experience any harm due to this instance.The surgery was a revision due to an outside trauma that the patient had suffered.The surrounding bone around the original implant was fractured to the point where a revision stem was needed to replace the original stem.
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that during the procedure the scrub tech had accidentally contaminated the screwdriver used to remove the tray from the trial stem and the surgeon attempted to remove it without the screw being fully backed out.That caused the screw to strip through the surrounding plastic threading.This caused almost no delay in the procedure and the patient did not experience any harm due to this instance.The surgery was a revision due to an outside trauma that the patient had suffered.The surrounding bone around the original implant was fractured to the point where a revision stem was needed to replace the original stem.
Additional Manufacturer Narrative
The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received device shows significant signs of extensive usage evident by appearance of worn-out surfaces & scratch marks.The white plastic part was found degraded & the device was completely broken which indicates towards frequent usage & improper handling.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on investigation, the root cause was attributed to a design related issue.A design change is in progress to avoid that the issue occurs again.If any further information is provided, the complaint report will be updated.

• Brand Name: ASC FLEX CENTERED REVERS PLATFORM TRIAL D40 TH 0 EXC 0 STD
• Common Device Name: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; postfach; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; postfach; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 13774997
• Report Number: 3000931034-2022-00147
• Device Sequence Number: 13868329
• Product Code: KWS
• UDI-Device Identifier: 03700386976889
• UDI-Public: 03700386976889
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K122698
• 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): 07/25/2022

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: Lay User/Patient
• Device Catalogue Number: MWF500S
• Device Lot Number: 18C802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/14/2022
• Supplement Date Received by Manufacturer: 06/27/2022
• Initial Report FDA Received Date: 03/15/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2018
• 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: 68 YR
• Patient Sex: Male