MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED 3.5 SCREWDRIVER HEXAGONAL TIP AO TYPE

Model Number	MWB991
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device not returned.
Event or Problem Description
During the procedure for a shoulder replacement, the screwdriver broke while screwing the screw into the implant.Part of the screwdriver got stuck in the implant, stopping it from being screwed in.The operator had to use a new implant.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.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.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
During the procedure for a shoulder replacement, the screwdriver broke while screwing the screw into the implant.Part of the screwdriver got stuck in the implant, stopping it from being screwed in.The operator had to use a new implant.
Event or Problem Description
During the procedure for a shoulder replacement, the screwdriver broke while screwing the screw into the implant.Part of the screwdriver got stuck in the implant, stopping it from being screwed in.The operator had to use a new implant.
Additional Manufacturer Narrative
Correction - please refer to d9 -the product was returned, h6 (method, results & conclusion codes).The reported event could be confirmed, since the device was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received device shows the broken hexagonal tip side shaft.The microscopic images of the hexagonal screwdriver rupture correspond to a brittle fracture caused by a bending overload, probably done during the central screw tightening step.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 user related issue.The failure was caused by a bending overload.Additionally since the device was manufactured back in 2011 therefore breakage as noted in the complaint is deemed possible due to multiple usage combined with multiple reprocessing cycles.If more information is provided, the case will be reassessed.

• Brand Name: AEQUALIS REVERSED 3.5 SCREWDRIVER HEXAGONAL TIP AO TYPE
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer (Section G): TORNIER S.A.S.; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16898763
• Report Number: 3000931034-2023-00131
• Device Sequence Number: 5371832
• Product Code: HXX
• UDI-Device Identifier: 03700386971006
• UDI-Public: (01)03700386971006(10)11C117
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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,Followup
• Report Date (Section B): 01/21/2025

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 Model Number: MWB991
• Device Catalogue Number: MWB991
• Device Lot Number: 11C117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 06/06/2023; 12/23/2024
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 06/30/2023; 01/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2011
• 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