MAUDE Adverse Event Report: TORNIER S.A.S AEQUALIS REVERSED; PROSTHESIS SHOULDER METAL

Model Number	LOCKING SCREW 4.5X41MM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/25/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Head of locking screw sheared off.Surgery was completed.Screw was left in baseplate.
Additional Manufacturer Narrative
On november "10st", 2020 stryker trauma and extremities acquired tornier (b)(4).An effort was made to align the acquired entity complaint files with stryker's policies and procedures.Stryker has performed retrospective review of complaints and the reportability decision was revised to report this incident under the mdr process.The threading portion of the screw under the head is missing.Left in baseplate.Surgery was completed (screw left in baseplate).The 3 other screws guarantee the stability of the implant.A review of the device history for the reported lot did not indicate any abnormalities.Screw rupture under head may be related to several reasons: in case of a motorized screwdriver use which may generate an excessive torque.In screwing on the last threads of the screw with a relatively dense bone in link with the screw length (41mm of length in this case).In case of a bad hexagonal gripping/fitting between the screw and the screwdriver.According to the data available and the analysis conducted on the device, the root cause could not be clearly determined.

• Brand Name: AEQUALIS REVERSED
• Common Device Name: PROSTHESIS SHOULDER METAL
• Manufacturer (Section D): TORNIER S.A.S; 161 rue lavoisier; montbonnot saint martin, ; FR
• Manufacturer Contact: laurent ray ; 161 rue lavoisier; montbonnot saint martin ; FR
• MDR Report Key: 13606742
• Report Number: 3000931034-2022-00059
• Device Sequence Number: 16636510
• Product Code: KWS
• UDI-Device Identifier: 03700386916694
• UDI-Public: 03700386916694
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K050316
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2016

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: LOCKING SCREW 4.5X41MM
• Device Catalogue Number: DWD041
• Device Lot Number: 1493AP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2016
• Initial Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown