MAUDE Adverse Event Report: TORNIER INC PERFORM REVERSED HALF MOON BASEPLATE REAMER 25MM; SCREWDRIVER

Model Number	MWJ109
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	06/29/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Sales rep injured himself with the handle of the tiller holder which resulted in accidental exposure to blood.The milling cutter was stuck in the milling tip.The event occurred during the operation, while removing the instrument from the handle.
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
Sales rep injured himself with the handle of the tiller holder which resulted in accidental exposure to blood.The milling cutter was stuck in the milling tip.The event occurred during the operation, while removing the instrument from the handle.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.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 the device is returned or if any additional information is provided, the investigation will be reassessed.H3 other text : device not returned.

• Brand Name: PERFORM REVERSED HALF MOON BASEPLATE REAMER 25MM
• 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: 15890510
• Report Number: 0001649390-2022-00112
• Device Sequence Number: 12437289
• Product Code: HXX
• UDI-Device Identifier: 00846832062324
• UDI-Public: 00846832062324
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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?: No
• Operator of Device: Other
• Device Model Number: MWJ109
• Device Catalogue Number: MWJ109
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 02/06/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown