MAUDE Adverse Event Report: TORNIER INC PERFORM REVERSED PERIPHERAL SCREW DRILL GUIDE; GUIDE, SURGICAL INSTRUMENT

Catalog Number MWJ124

Device Problem Residue After Decontamination (2325)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2023

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

As reported: "the scrub could not get the disposable drill bit through the peripheral drill guide mwj124.After pushing through a lot of black dirt (old blood) came out and was spread over the tray.We were forced to move to rev ii with bio rsa.Patient got a different glenoid option than discussed.Surgeon was forced to move to different glenoid option." update: reversed ii option was indeed successful to complete the surgery.

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 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.More detailed information about the complaint event as well as the affected device must be available in order to determine the exact root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.H3 other text: device disposition unknown.

Event Description

As reported: "the scrub could not get the disposable drill bit through the peripheral drill guide mwj124.After pushing through a lot of black dirt (old blood) came out and was spread over the tray.We were forced to move to rev ii with bio rsa.Patient got a different glenoid option than discussed.Surgeon was forced to move to different glenoid option." update: reversed ii option was indeed successful to complete the surgery.

• Brand Name: PERFORM REVERSED PERIPHERAL SCREW DRILL GUIDE
• Type of Device: GUIDE, SURGICAL INSTRUMENT
• 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: 18314447
• MDR Text Key: 330326893
• Report Number: 0001649390-2023-00343
• Device Sequence Number: 1
• Product Code: FZX
• UDI-Device Identifier: 00846832062478
• UDI-Public: 00846832062478
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MWJ124
• Device Lot Number: AZ2421236
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Male