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

Model Number	DWD167
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/07/2022
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 patient was undergoing a left reverse total shoulder arthroplasty, when the tip of a single use screwdriver used to place the implant broke off in the patient as the doctor was tightening the implant into position.The screwdriver was a single use device provided by the tornier rep.The rep advised the doctor that the screwdriver tip is in fact secure in place in the implant and will not move and the only way to remove it is to completely drill out the implant.The doctor understood the situation and their decision was to leave the current implant in place with the screwdriver tip secured in the implant.The drill was removed from the sterile field, labeled, and placed in biohazard bag that was given to manager in spd, who was advised of the situation with the drill, and they were instructed to clean the remaining piece for further follow up.
Event or Problem Description
It was reported that the patient was undergoing a left reverse total shoulder arthroplasty, when the tip of a single use screwdriver used to place the implant broke off in the patient as the doctor was tightening the implant into position.The screwdriver was a single use device provided by the tornier rep.The rep advised the doctor that the screwdriver tip is in fact secure in place in the implant and will not move and the only way to remove it is to completely drill out the implant.The doctor understood the situation and their decision was to leave the current implant in place with the screwdriver tip secured in the implant.The drill was removed from the sterile field, labeled, and placed in biohazard bag that was given to manager in spd, who was advised of the situation with the drill, and they were instructed to clean the remaining piece for further follow up.
Additional Manufacturer Narrative
Please note the correction to the d4 serial number: the reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received device shows signs of frequent usage as evident by wear & tear marks over the entire surface.The hexagonal tip also has deformed edges.The breakage in the tip indicates towards an application of high torsional load during use.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 combination of user related issue.The breakage is due to an application of high torsional load.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: BIT, DRILL
• 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: 15809866
• Report Number: 3000931034-2022-00368
• Device Sequence Number: 14856971
• Product Code: HTW
• UDI-Device Identifier: 03700386943775
• UDI-Public: 03700386943775
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2023

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: DWD167
• Device Catalogue Number: DWD167
• Device Lot Number: 0892AX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2022
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 11/16/2022
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2022
• 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
• Patient Sex: Unknown