MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - SCREWDRIVERS; SURGICAL SCREWDRIVER, REUSABLE

Catalog Number UNK - SCREWDRIVERS

Device Problem Failure to Clean Adequately (4048)

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2009

Event Type  Injury  

Manufacturer Narrative

Brand name, common device name, procode, mfr, lot #, part #, udi #, 510k: this report is for an unknown screw driver.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Concomitant medical products: unknown bio-intrafix.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Device evaluated by mfr, manufacture date: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: parada et al, 2009, ¿instrumentation-specific infection after anterior cruciate ligament reconstruction¿, sports health, vol.1 no.6, usa.The study emphasizes on the relationship between methodological sterilization failure and acl reconstruction infection at an army medical center.The patients evaluated on course of this study: demographic, clinical, and laboratory data were collected on 5 postoperative infections during a 14-week period in 2003.All acl reconstructions completed within the past 6 years at the institution were reviewed to establish a baseline infection rate.The article describes the following procedure: acl procedure with hamstring autograft with the same tibial fixation.The devices involved were: all 5 cases used hamstring autograft with the same tibial fixation, the depuy mitek intrafix system.Four of these cases used the depuy mitek slingshot system(hex driver) for femoral fixation of the graft.The arthrex transfix system was used for the femoral fixation in the remaining case.Complications mentioned in the article were: infections, pains identified are due to remaining biomaterial found inside the intrafix tibial fixation hex driver.Patient cultures were negative.Patient was treated with antibiotic for four weeks.From the review of the article it is concluded that the biomaterial inside the intrafix tibial fixation hex driver caused the infections and pains.

Manufacturer Narrative

Depuy is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy or its employees that the report constitutes an admission that the device, depuy , or its employees caused or contributed to the potential event described in this report.

• Brand Name: UNK - SCREWDRIVERS
• Type of Device: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8777835
• MDR Text Key: 150617659
• Report Number: 1221934-2019-57595
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 06/21/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: UNK - SCREWDRIVERS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/21/2019
• Initial Date FDA Received: 07/10/2019
• Supplement Dates Manufacturer Received: 06/21/2019
• Supplement Dates FDA Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR