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

Model Number	71158019
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Type of Reportable Event	Serious Injury
Event or Problem 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 experienced the rupture of the flexor pollicis longus tendon which required the plate removal on an unknown date.The patient had achieved radiographic union of the fracture 1.5 months post initial implantation.No further information is available.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: 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 (pmcf) 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 impact to the patient beyond that which has already been reported cannot be confirmed nor concluded based on the information provided.Therefore, no further medical assessment is warranted 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 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, 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.We consider this investigation closed.Internal complaint reference number: (b)(4).
Additional Manufacturer Narrative
Corrected data: b5 (narrative), g2 (source: pmcf conducted in the uk), h6 (health effect - impact code).H11: additional information has been received from the site conducting this pmcf.
Event or Problem 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 experienced the rupture of the flexor pollicis longus tendon at three (3) months postoperatively which required the plate removal and thumb ipj fusion an unknown date at six (6) months postoperatively.The patient had achieved radiographic union of the fracture 1.5 months post initial implantation.The patient's symptoms have completely resolved and is back to usual activities.No further information is available.
Additional Manufacturer Narrative
Corrected data: h6 (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, there were no clinical factors found which would have caused or contributed to the reported fracture collapse.Consequently, a thorough medical investigation cannot be rendered, nor could a definitive clinical root cause of the reported failure be determined.Per the report, the patient experienced the rupture of the flexor pollicis longus tendon at three (3) months postoperatively which required the plate removal and thumb interphalangeal joint fusion an unknown date at six (6) months postoperatively.It was also reported the patient achieved union of the fracture.Therefore, impact to the patient beyond that which has already been reported cannot be confirmed nor concluded no further clinical/medical assessment is warranted at this time.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, patient condition or postoperative care.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 LEFT STANDARD PLATE
• Common Device Name: 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: 15636028
• Report Number: 1020279-2022-04500
• Device Sequence Number: 7179113
• Product Code: HRS
• UDI-Device Identifier: 00885556364444
• UDI-Public: 00885556364444
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K132296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 71158019
• Device Catalogue Number: 71158019
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2022
• Supplement Date Received by Manufacturer: 10/21/2022; 03/20/2023; 05/18/2023
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 10/26/2022; 03/31/2023; 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown