MAUDE Adverse Event Report: TORNIER S.A.S. UNKNOWN_WRIGHT TORNIER-MONTBONNOT_PRODUCT; SCREWDRIVER

Catalog Number UNK_WTM

Device Problems Inadequate Instructions for Healthcare Professional (1319); Component Missing (2306)

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

Event Date 06/27/2023

Event Type  malfunction  

Event Description

It was reported that "the loan was unsuitable for equipment withdrawal".The surgeon could not remove the glenosphere (3.5 screwdriver) because there wasn't one in the kit.The surgery was indeed lengthened, but the placement of a reverse prosthesis could be performed.

Manufacturer Narrative

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

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.Based on investigation, the root cause was attributed to a distribution error related issue.The event was caused by the absence of screwdriver 3.5 mm in the tornier extraction instruments.In complement of the tornier extraction instruments the instrumentation set of the prosthesis removed is needed for the explantation of the prosthesis.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.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.

Event Description

It was reported that "the loan was unsuitable for equipment withdrawal".The surgeon could not remove the glenosphere (3.5 screwdriver) because there wasn't one in the kit.The surgery was indeed lengthened, but the placement of a reverse prosthesis could be performed.

• Brand Name: UNKNOWN_WRIGHT TORNIER-MONTBONNOT_PRODUCT
• Type of Device: SCREWDRIVER
• 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: 17381257
• MDR Text Key: 319764848
• Report Number: 3000931034-2023-00220
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 12/08/2023

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WTM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 11/15/2023
• Supplement Dates FDA Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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