MAUDE Adverse Event Report: HOWMEDICA OSTEONICS CORP STRYKER SCREW FEM 10.5X105MM GAMMA 3 LAG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Lot Number KOAOB2F

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 08/30/2021

Event Type  Injury  

Event Description

Short troch nail required a revision a year postoperatively (original surgery (b)(6) 2020).The top of the troch nail broke off and the lag screw through the nail broke.Fda safety report id # (b)(4).

• Brand Name: STRYKER SCREW FEM 10.5X105MM GAMMA 3 LAG
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): HOWMEDICA OSTEONICS CORP
• MDR Report Key: 12413998
• MDR Text Key: 270052962
• Report Number: MW5103685
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/31/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: KOAOB2F
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 72