MAUDE Adverse Event Report: TORNIER S.A.S. AEQUALIS REVERSED HEX SCREW DRIVER BIT D3.5MM L25MM; SURGICAL SCREWDRIVER, REUSABLE

Model Number	DIAM 3.5MM LENGTH 25MM
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
On (b)(6) 2021 -the surgeon was performing a reverse total shoulder arthroplasty today on a nickel allergy patient, and while attempting to tighten down a titanium 36/25 glenosphere, a brand new 3.5 hex driver tip broke off onto the glenosphere.He was on his final turn when the tip snapped off.We attempted to use a dental pick and a few different burrs to loosen the tip, but no luck.The tip of the hex driver was flush inside of the sphere.The surgeon did not think the glenosphere or baseplate had been compromised and decided to leave the tip in.There was no reported delay or adverse consequence.The tip that was left in the glenosphere was very small, it ended up being flush.
Event or Problem Description
(b)(6) 2021 -the surgeon was performing a reverse total shoulder arthroplasty today on a nickel allergy patient, and while attempting to tighten down a titanium 36/25 glenosphere, a brand new 3.5 hex driver tip broke off onto the glenosphere.He was on his final turn when the tip snapped off.We attempted to use a dental pick and a few different burrs to loosen the tip, but no luck.The tip of the hex driver was flush inside of the sphere.The surgeon did not think the glenosphere or baseplate had been compromised and decided to leave the tip in.There was no reported delay or adverse consequence.The tip that was left in the glenosphere was very small, it ended up being flush.
Additional Manufacturer Narrative
Correction to h3 and h6 device code.The reported event that the screwdriver was alleged of issue ¿instrument - breakage during implantation¿ could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the device was received with broken tip.The broken tip of the hexagonal screwdriver rupture corresponded to a fracture caused by a torsional overload, where the tip twisted-off in the right direction (during screw tightening, confirmed by the direction of material deformation at the breakage line).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 user related issue.The failure was caused by an overstress applied on the tip during use when tightening the screw inside the glenosphere.If any further information is provided, the complaint report will be updated.

• Brand Name: AEQUALIS REVERSED HEX SCREW DRIVER BIT D3.5MM L25MM
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• 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: janice mithouard ; 161 rue lavoisier; montbonnot saint-martin 38330 ; FR 38330 ; 476613500
• MDR Report Key: 11931079
• Report Number: 3000931034-2021-00261
• Device Sequence Number: 4259571
• Product Code: HTW
• UDI-Device Identifier: 03700386943775
• UDI-Public: 03700386943775
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 11/05/2021
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 09/15/2025
• Device Model Number: DIAM 3.5MM LENGTH 25MM
• Device Catalogue Number: DWD167
• Device Lot Number: 6001AV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 11/05/2021
• Initial Report FDA Received Date: 06/03/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown