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	Foreign Body In Patient (2687)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that the tip broke off inside of the glenosphere during implantation.Glenosphere was well attached.Surgeon did not attempt to remove the tip out of the glenosphere despite encouragement to do so.
Event or Problem Description
It was reported that the tip broke off inside of the glenosphere during implantation.Glenosphere was well attached.Surgeon did not attempt to remove the tip out of the glenosphere despite encouragement to do so.
Additional Manufacturer Narrative
Correction d4 lot, d9/h3 the reported event could be confirmed, based on the image provided by the complainant.The device inspection revealed the following: the visual inspection of the device shown in the provided image confirms the broken hexagonal tip.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.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 exact root cause of the complaint event.If device is returned or any further information is provided, the investigation report 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: 17059137
• Report Number: 3000931034-2023-00176
• Device Sequence Number: 5164027
• Product Code: HXX
• UDI-Device Identifier: 03700386971006
• UDI-Public: 03700386971006
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 07/25/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 06/05/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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