MAUDE Adverse Event Report: TORNIER INC CANNULATED REAMER DRIVER; BIT, SURGICAL

Model Number	MWE151
Medical Device Problem Code	Residue After Decontamination (2325)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/29/2022
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 tornier surgical instrument company representative delivered five cannulated instruments with extensive debris and residue inside the channels.The residue appeared to be rust, chemical residue, and possible bioburden.The instruments were loaner instruments that were delivered by the milwaukee wisconsin area representative for tornier.The five instruments, which were cannulated drill/drivers, were part of the aequlais perform glenoid system.
Additional Manufacturer Narrative
The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.A review of the device history for the reported lot did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.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.If device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
It was reported that the tornier surgical instrument company representative delivered five cannulated instruments with extensive debris and residue inside the channels.The residue appeared to be rust, chemical residue, and possible bioburden.The instruments were loaner instruments that were delivered by the milwaukee wisconsin area representative for tornier.The five instruments, which were cannulated drill/drivers, were part of the aequlais perform glenoid system.

• Brand Name: CANNULATED REAMER DRIVER
• Common Device Name: BIT, SURGICAL
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• 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: 15490880
• Report Number: 0001649390-2022-00072
• Device Sequence Number: 19309053
• Product Code: GFG
• UDI-Device Identifier: 03700386973871
• UDI-Public: 03700386973871
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

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 Model Number: MWE151
• Device Catalogue Number: MWE151
• Device Lot Number: 20C805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/29/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 11/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2020
• 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