MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.0MM F-T CAC SCRW 45MM; PLATE, FIXATION, BONE

Model Number 71805245

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/17/2020

Event Type  Injury  

Event Description

It was reported that the surgeon was hand tightening a periloc 4.0 x 45mm fully threaded cancellous screw in to the patient's tibia when the head of the screw broke.The broken part fell inside the patient and could not be retrieved successfully.A delay of 0 to 30 minutes reported.An s&n backup was available.No additional patient injuries reported, other than the broken piece remaining inside.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical evaluation concluded that the head of a cancellous peri-loc screw broke and fell inside the patient, and could not be retrieved successfully.However, per email communication from the sales rep, - "the broken screw head was retrieved, the body of the screw remains in the patient¿s tibia.There is no plan, or way to retrieve this." per complaint details, there was no injuries to patient, and no delay.Therefore, since the broken piece was retrieved, no further assessment is warranted at this time.A complaint history review found related failures; this failure mode will be monitored for future complaints and assessed for any necessary corrective actions.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Potential probable causes could be but are not limited to design of device, improper size of device used, material in use, procedural/user error, and unclear user instructions.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: 4.0MM F-T CAC SCRW 45MM
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10280698
• MDR Text Key: 199044640
• Report Number: 1020279-2020-03249
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 03596010521729
• UDI-Public: 03596010521729
• Combination Product (y/n): N
• PMA/PMN Number: K033669
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71805245
• Device Catalogue Number: 71805245
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other