MAUDE Adverse Event Report: TORNIER S.A.S. CANNULATED DRILL/REAMER DRIVER TIP; BIT, SURGICAL

Model Number MWE152

Device Problem Residue After Decontamination (2325)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2022

Event Type  malfunction  

Event 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.

Manufacturer Narrative

Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.The device disposition is unknown.

Manufacturer Narrative

Please note the corrections in h6 clinical signs code and the health impact code: 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 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 DRILL/REAMER DRIVER TIP
• Type of Device: BIT, SURGICAL
• 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: 15487237
• MDR Text Key: 300906258
• Report Number: 3000931034-2022-00329
• Device Sequence Number: 1
• Product Code: GFG
• UDI-Device Identifier: 03700386973888
• UDI-Public: 03700386973888
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MWE152
• Device Catalogue Number: MWE152
• Device Lot Number: 20C291
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1