MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PERILOC 4.5 PRX TIB PL TEMPLAT; PLATE, FIXATION, BONE

Catalog Number 71180916

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation/ Irritation (4545)

Event Date 01/01/1901

Event Type  Injury  

Event Description

It was reported that a revision surgery had been performed to remove the peri-loc large frag 4.5 l-p tibia plate and screw.It is unknown if there were any delays, injuries or how the secondary procedure was completed.

Manufacturer Narrative

The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms per e-mail communication it is unknown if the reported procedure to remove the plate and screw was planned by surgeon since the beginning of treatment or if the procedure was a revision to alleviate the patient from hardware prominence and soft tissue irritation.No relevant supporting clinical information has been provided to assist with a clinical investigation.The patient's current condition is unknown and the patient impact beyond the reported events could not be determined based on the limited information provided.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time.Should any additional clinical information be provided this complaint will be re-evaluated.A review of complaint history did not reveal additional complaints for the listed device.Device specific batch information was not provided.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Factors and/or some potential probable causes that could contribute to the reported event have been identified as overuse or excessive pressure on the joint, injury, infection and/or patient condition.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: PERILOC 4.5 PRX TIB PL TEMPLAT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11548669
• MDR Text Key: 241670978
• Report Number: 1020279-2021-02317
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556191743
• UDI-Public: 885556191743
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71180916
• Device Lot Number: TBD
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention