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

Model Number 71158020

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Non-union Bone Fracture (2369)

Event Date 01/01/1901

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 the nonunion of the fracture along with pain and an unexpected decrease in range of motion.Although the patient was followed up for eight (8) postoperative months, an onset date for the reported symptoms is not known.The patient's outcome, as well as any measures taken to resolve these complications remain unknown.

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, as of the date of this investigation, the requested clinical documentation has not been provided; therefore, there were no clinical factors found which would have contributed to the event.The data was collected from the post-market clinical follow up activity was anonymous, no further information will be provided.Consequently, without the requested clinical information, a thorough clinical assessment cannot be performed at this time.The root cause and/or patient outcome beyond that which was documented in the article could not be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.Should any additional relevant medical information be provided, this case would be re-assessed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for d-rad smart pack system revealed that there are physical conditions that would preclude adequate implant support or retard healing, such as, blood supply impairment, insufficient bone quality or quantity, previous infection, obesity, severe bow or gross distortion of the radius, this has been identified as contraindications.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 excessive pressure on the joint, injury, procedural/user error, surgical/post operative complications, healing issues and/or patient condition.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: case-2022-00124167-1.

Manufacturer Narrative

Corrected data: b5 (narrative), g2 (other - specify: data from a pmcf conducted in the uk).

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 the collapse of the distal radius with nonunion of the fracture along with pain and an unexpected decrease in range of motion at six (6) months postoperatively.Although the patient was subsequently discharged and followed up for eight (8) postoperative months, an onset date for the reported symptoms is not known.The patient has not re-presented to the healthcare facility but was advised that we would require fusion if the nonunion became symptomatic.The patient's outcome is unknown.

Manufacturer Narrative

H11: updated results of investigation: given the nature of the alleged incident, the device, could not be returned for evaluation.The clinical/medical investigation concluded that, without patient-specific clinically relevant supporting documentation or the device the reported adverse event at six months postop cannot be confirmed; nor could a definitive clinical root cause of the reported event be determined.Per the complaint, this patient was discharged and followed for 8 months, however, the onset of the patient¿s symptoms is unknown.It has been reported, the patient seems to be doing well now with partial symptom resolution of symptoms and has been discharged from clinic.Per report, the patient has been advised a fusion of the nonunion maybe required if become symptomatic.Therefore, since it was reported the patient only achieved partial symptom resolution of symptoms, the impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for d-rad smart pack¿ system revealed in the contraindications section that there are physical conditions that would preclude adequate implant support or retard healing, such as, blood supply impairment, insufficient bone quality or quantity, previous infection, obesity, severe bow or gross distortion of the radius.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 specifications at the time of manufacture.Factors that could contribute to the reported event include excessive pressure on the joint, injury, procedural/user error, surgical/post operative complications, healing issues and/or patient condition.Based on this investigation, the need for corrective action is not indicated.Should 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 LEFT WIDE 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: 15635943
• MDR Text Key: 302054374
• Report Number: 1020279-2022-04496
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 00885556364499
• UDI-Public: 00885556364499
• 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: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71158020
• Device Catalogue Number: 71158020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2023
• 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): Other