MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM X 42MM CORT BONE SCR ST SST; PLATE, FIXATION, BONE

Model Number 3571129242

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/13/2021

Event Type  Injury  

Event Description

It was reported that, during a thr, two (2) 4.5mm x 44mm cort bone scr st sst and two (2) 4.5mm x 42mm cort bone scr st sst, were difficult to start insertion of a chs 4 hole 130 deg plate.Surgeon stated that the drill hole had been placed in freehand, therefore was too close to the plate for the screw to bite evenly.The procedure was completed with the same reported screws.However, it is unknown if there was a delayed or not.Patient was not injured as consequence of this problem.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Possible causes could include but are not limited to alignment and procedural/user error or variance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, 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.

• Brand Name: 4.5MM X 42MM CORT BONE SCR ST SST
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 12233226
• MDR Text Key: 263845612
• Report Number: 1020279-2021-06043
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 03596010552150
• UDI-Public: 03596010552150
• Combination Product (y/n): N
• PMA/PMN Number: K993106
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3571129242
• Device Catalogue Number: 3571129242
• Device Lot Number: 21CT47171
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention