MAUDE Adverse Event Report: SMITH & NEPHEW, INC. D-RAD PLATE TEMPLATES LEFT; PLATE, FIXATION, BONE

Catalog Number 71158017

Device Problem Defective Device (2588)

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

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that, during an unspecified surgery, at the time of placing a locked screw in the most distal and external part of the d-rad plate templates left, it was completely inserted into the bone, when checking the plate it had a defect, it no longer had a star shape in the hole.However, it was ensured that the plate was locking correctly and the procedure was successfully completed with the same device.A delay less than or equal to 30mins was reported.No other complications were reported.

Manufacturer Narrative

H6: 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.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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: D-RAD PLATE TEMPLATES LEFT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11135894
• MDR Text Key: 225719831
• Report Number: 1020279-2021-00192
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• PMA/PMN Number: K132296
• 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: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2021
• Device Catalogue Number: 71158017
• Device Lot Number: 16EM14712
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention