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

Model Number	MWJ128
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Implant Pain (4561)
Date of Event	07/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that were was an incision and drainage needed for a patient.There was puss and pain reported.
Additional 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.The device disposition is unknown.
Additional 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.
Event or Problem Description
It was reported that were was an incision and drainage needed for a patient.There was puss and pain reported.

• Brand Name: PERFORM REVERSED RATCHETING SCREWDRIVER HANDLE
• Common Device Name: 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: 15471601
• Report Number: 0001649390-2022-00069
• Device Sequence Number: 2919136
• Product Code: LXH
• UDI-Device Identifier: 00846832062508
• UDI-Public: 00846832062508
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/25/2022
• Supplement Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2923757
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male