MAUDE Adverse Event Report: TORNIER INC PERFORM REVERSED RATCHETING SCREWDRIVER HANDLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number MWJ128

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Purulent Discharge (1812); Implant Pain (4561)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.Upon completion of the investigation, additional information will be provided in a supplemental report.

Event Description

It was reported that during a post op visit, the patient's shoulder showed puss.C acnes was noted on (b)(6) 2022.There was a revision to the antibiotic spacer.

Event Description

It was reported that during a post op visit, the patient's shoulder showed puss.C acnes was noted on (b)(6) 2022.There was a revision to the antibiotic spacer.

Manufacturer Narrative

The reported event could not be confirmed.A device inspection was not possible because the affected device was not returned.However, due to the contamination the device would incur during transport for investigation, allegations of infection would not be able to be determined based on any inspection effort.Because the affected device was not returned and the lot number was not communicated, the batch record could not be reviewed.This review is necessary to the investigation for the alleged issue of infection.The risk of the infection noted in this complaint from the perform reversed ratcheting screwdrivers handle is very low.A review of the labeling did not indicate any abnormalities.More information must be available in order to determine the exact root cause of the alleged infection.In case the item and/or substantive information will become available in future that suggests otherwise; the file will be reviewed.

• Brand Name: PERFORM REVERSED RATCHETING SCREWDRIVER HANDLE
• Type of Device: ORTHOPEDIC MANUAL 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: 15471132
• MDR Text Key: 300452701
• Report Number: 0001649390-2022-00067
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00846832062508
• UDI-Public: 00846832062508
• 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: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MWJ128
• Device Catalogue Number: MWJ128
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2923757
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male