MAUDE Adverse Event Report: TORNIER INC LATITUDE EV SCREWDRIVER BIT 2,5 MM

Catalog Number	9030375
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/04/2022
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 tip of the driver broke of in the screw head and remained in the patient.This caused a 2 minute delay in surgery.
Additional Manufacturer Narrative
The reported event could be confirmed.The device was returned and found to be in the condition stated in the event description.Based on the investigation, the root cause was attributed to misuse of the device / failure to follow the surgical technique.The returned device showed signs of intense usage.The hex tip was broken, blunt, and appeared to be slightly twisted.This confirms a sudden brittle fracture.All these signs are evident enough to suggest that there was intense usage of the driver including high torsional and bending load which led to a forced fracture.A review of the device history for the reported lots did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the complaint report will be updated.
Event or Problem Description
It was reported that the tip of the driver broke of in the screw head and remained in the patient.This caused a 2 minute delay in surgery.

• Brand Name: LATITUDE EV SCREWDRIVER BIT 2,5 MM
• 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: 13636174
• Report Number: 3004983210-2022-00042
• Device Sequence Number: 17443713
• Product Code: HXX
• UDI-Device Identifier: 00846832019991
• UDI-Public: 00846832019991
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2022

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: Health Professional
• Device Catalogue Number: 9030375
• Device Lot Number: BA0121092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 06/29/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2021
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown