MAUDE Adverse Event Report: SYNTHES (U.S.A.) LP 4.0MM CANNULATED SCREW SHORT THREAD/34MM; SCREW, FIXATION, BONE

Model Number 207.634

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/19/2021

Event Type  malfunction  

Event Description

Patient in surgery for displaced right distal humerus medial epicondyle fracture due to a dodgeball throwing injury.Patient also has history of growth hormone deficiency as well of the medial elbow bone.Surgeon placed a synthes 34mm (4.0 cannulated) screw and went to remove it.The screw head broke off.The decision was made to leave the threads in place and place other shorter screws.Surgeon then used the slightly anterior pin to place a second screw with washer.This achieved a very solid bite into the metaphyseal bone and appeared to secure the fragment quite well.The transverse wire was then repositioned and over drilled, followed by placement of a third screw.Both screws were tightened down.Image confirmed good alignment of the screws and positioning of the fragment.The portion of the screw that broke was given to the material manager so she could contact the manufacturer.

• Brand Name: 4.0MM CANNULATED SCREW SHORT THREAD/34MM
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES (U.S.A.) LP; 1301 goshen pkwy; west chester PA 19380
• MDR Report Key: 11607167
• MDR Text Key: 243619532
• Report Number: 11607167
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 207.634
• Device Catalogue Number: 207.634
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5110 DA
• Patient Weight: 58