MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. SCREWDRIVER; KNEE INSTRUMENT

Model Number	18410135
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, screwdriver broke off in the stem extractor.Surgery was extended greater than 30 minutes.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Additional Manufacturer Narrative
The alleged complaint is confirmed.The product was returned for investigation.Examination of the returned product confirmed that it had sustained damage.The hex tip had fractured and was stuck in the mating component of the stem extractor.It is likely that hex geometry had sustained damage and became stuck leading to fracture under force.The instruments were well worn and old judging from the appearance and lot numbers.The hex edges can wear of years of use, and this issue is largely unavoidable over the lifetime of the instrument.This instrument was purchased in 2006.Review of the device history record for this lot indicates that this product met all acceptance criteria at the time of manufacturing.There were no trends identified for this instrument and complaint type.This is the only complaint for this lot and the first complaint for the product since 2022.The microport instrument cleaning and handling instructions (150802) indicate that the instruments are susceptible to damage over time and should be inspected prior to and after each use.In addition, the cleaning and handling instructions also state, "end of functional life is normally determined by wear and damage due to use." this complaint is addressed by wd014283 - common instrument failure modes memo.This issue will continue to be monitored through complaint tracking.
Event or Problem Description
Allegedly, screwdriver broke off in the stem extractor.The surgery was extended greater than 30 minutes.

• Brand Name: SCREWDRIVER
• Common Device Name: KNEE INSTRUMENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 21230639
• Report Number: 3010536692-2025-00015
• Device Sequence Number: 15338901
• Product Code: HXX
• UDI-Device Identifier: M684184101351
• UDI-Public: M684184101351
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2025

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: Other
• Device Model Number: 18410135
• Device Catalogue Number: 18410135
• Device Lot Number: 332719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/24/2025
• Supplement Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown