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

Catalog Number	MWB991
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
After applying the glenosphere to the metaglene plate, a part broke off after one turn of the screwdriver.The part in question is stuck in the screw hole below the level of the glenosphere.All attempts to remove both the broken part and the entire glenosphere failed.The glenosphere was solidly welded.There was a delay in surgery.
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.

• 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: 13776713
• Report Number: 3000931034-2022-00148
• Device Sequence Number: 1661248
• Product Code: HXX
• UDI-Device Identifier: 03700386971006
• UDI-Public: 03700386971006
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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
• Report Date (Section B): 03/15/2022

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: 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: 02/18/2022
• Initial Report FDA Received Date: 03/15/2022
• 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