MAUDE Adverse Event Report: DEPUY SYNTHES DEPUY SYNTHES 7.3 CANNULATED SCREWDRIVER SYSTEM

Device Problem Break (1069)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Date 10/24/2019

Event Type  Injury  

Event Description

Patient had a previous left hip fracture post internal fixation-healed, but having pain in the left hip attributed to the hardware.During the surgery on (b)(6) 2019, the first two screws were extracted using a manual driver, screws retrieved.On the final screw, the cannulated screw drier broke in the screw head and the metal fragments were excised using c-arm imaging and a kocher.The stripped screw was excised using a combination of an additional driver, plyers, kocher, and other techniques.An x-ray was obtained prior to closure, residual small fragment left behind due to depth and location.The surgeon ¿felt retrieving this fragment would require a larger incision, and potential muscle destruction to obtain visualization and removal and due to its location.¿ fda safety report id # (b)(4).

• Brand Name: DEPUY SYNTHES 7.3 CANNULATED SCREWDRIVER SYSTEM
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): DEPUY SYNTHES; palm beach gardens FL 33410
• MDR Report Key: 9317210
• MDR Text Key: 166537295
• Report Number: MW5091039
• Device Sequence Number: 1
• Product Code: HXX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/07/2019

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2019
• 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): Other
• Patient Age: 65 YR
• Patient Weight: 123