MAUDE Adverse Event Report: SMITH & NEPHEW, INC. D-RAD SMART PACK 4H RIGHT STANDARD PLATE; PLATE, FIXATION, BONE

Model Number 71158021

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

Patient Problems Pain (1994); Implant Pain (4561)

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, following an internal fixation surgery performed on an unspecified date to treat a radius fracture with a d-rad single use kit plating system, the patient sustained pain over palpable plate that made necessary the removal of the plate.Although the patient was followed up for twenty nine (29) postoperative months, an onset date for the reported symptoms and a date of surgery for the plate removal is not known.The patient had achieved radiographic union of the fracture 1.5 months post initial implantation.No further information is available.

Manufacturer Narrative

Section h10: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a revision (planned removal) was performed following a modified henry/radius fracture fixation utilizing the standard (right) d-rad kit due to the patient experienced pain over palpable plate (limited pain/limited function impairment).Although the patient was followed for twenty nine (29) postoperative months, the onset date for the reported symptoms and revision date of plate removal is unknown; however, successful bony union with radiographic confirmation was reported to have occurred at 1.5 months post-op with an expected rom.The data was obtained from a retrospective post-market clinical follow-up and as of the date of this medical investigation, no supporting clinical documentation has been provided; therefore, contributing clinical factors could not be concluded and it cannot be concluded that there was a malperformance of the s+n component(s).With the limited information provided, the patient impact beyond the reported "pain over palpable plate" and subsequent removal cannot be determined.No further medical assessment can be rendered at this time.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for d-rad smart pack¿ system revealed that fracture fixation devices are only used to aid in healing; they are not a substitute for normal intact tissue or bone.The anatomy of human bones presents limitations with respect to the size or thickness of bone screws or plates, thus the strength of implants is limited.Repeated stress will cause the implant malperfomrance.Postoperative instructions to patients and appropriate nursing care are critical.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness, patient condition or postoperative care.The contribution of the device to the reported event could not be corroborated.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.Internal complaint reference number: (b)(4).

Manufacturer Narrative

Corrected data: b5 (narrative), g2 (source: pmcf conducted in the uk).H11: additional information has been received from the site conducting this pmcf.

Event Description

It was reported that, following an internal fixation surgery performed on an unspecified date to treat a radius fracture with a d-rad single use kit plating system, the patient sustained pain due to plate prominence over radial styloid that made necessary the removal of the plate twenty-six (26) months postoperatively.Although the patient was followed up for twenty nine (29) postoperative months, an onset date for the reported symptoms and a date of surgery for the plate removal is not known.The patient had achieved radiographic union of the fracture 1.5 months post initial implantation and made excellent progress with her wrist.No further information is available.

Manufacturer Narrative

Corrected data: h6 (health effect - clinical code, health effect - impact code).Updated results of investigation: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, based on a review of the information provided, the patient began experiencing pain at 26 months post-operatively.However, it was further noted the patient had achieved radiographic union of the fracture 1.5 months post initial implantation and made excellent progress with her wrist.The 26-month period of the device remaining implanted cannot be excluded as a contributory factor to the pain that led to the surgical removal of the plate.Therefore, the impact to the patient beyond that which has already reported cannot be confirmed nor concluded.Should any additional relevant medical information be provided, this case would be re-assessed.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed similar events for the listed device, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the instructions for use documents for d-rad smart pack¿ system provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include traumatic injury, joint tightness or patient condition.Based on this investigation, the need for corrective action is not indicated.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 SMART PACK 4H RIGHT STANDARD PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15656522
• MDR Text Key: 302249953
• Report Number: 1020279-2022-04520
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556364543
• UDI-Public: 00885556364543
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K132296
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71158021
• Device Catalogue Number: 71158021
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention