MAUDE Adverse Event Report: TORNIER INC AEQUALIS REVERSED 3.5 SCREWDRIVER HEXAGONAL TIP AO TYPE

Catalog Number	MWB991
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
07/26/2023 tm the mdr is pending required code updates and complaint approval.The reported event was confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received device shows the broken hexagonal tip.The microscopic images of the hexagonal screwdriver rupture corresponded to a brittle fracture caused by a torsional overload which is caused during the tightening process.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 the torsional overloading.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that a small screwdriver tip broken off when performing double locking of sphere taper lock and center pin during glenoid sphere placement on the glenoid fossa.There is a large possibility of the fragment residual in the patient body.
Additional Manufacturer Narrative
Please note the corrections regarding h6 (clinical and health code): the reported event was confirmed, since the product was returned for evaluation.And matches the alleged failure mode.The device inspection revealed, the following: the received device shows the broken hexagonal tip.The microscopic images of the hexagonal screwdriver rupture corresponded to a brittle fracture caused by a torsional overload.Which is caused, during the tightening process.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 the torsional overloading.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported, that a small screwdriver tip broken off.When performing double locking of sphere taper lock and center pin, during glenoid sphere placement on the glenoid fossa.There is a large possibility of the fragment residual in the patient body.

• Brand Name: AEQUALIS REVERSED 3.5 SCREWDRIVER HEXAGONAL TIP AO TYPE
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17401912
• Report Number: 0001649390-2023-00173
• Device Sequence Number: 5900656
• Product Code: HXX
• UDI-Device Identifier: 03700386971006
• UDI-Public: 03700386971006
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: MWB991
• Device Lot Number: 21C795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2021
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown