MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TAN/FAN RADILUCENT DROP; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71631022
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	Deformity/ Disfigurement (2360)
Date of Event	05/11/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during the osteosynthesis surgery performed on (b)(6) 2022, the surgeon could not place the 6.4 solid hip screws in the nail.As reported, when passing the drill bit through the tan/fan radilucent drop, it would not target the nail correctly.The surgeon questioned the correct calibration of the device.When the device was checked outside the patient, it was working., therefore the surgeon suspected that the drop was damaged while inserting the nail in the patient.As no other option was available at the time, the surgeon completed the procedure using the same devices resulting in a femoral neck mal-reduction.The patient underwent an unspecified intervention to address the issue on (b)(6) 2022.
Additional Manufacturer Narrative
The device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, without the supporting information the root cause of the event cannot be confirmed, nor could it be concluded that the issue was caused by a mal performance of the device or the surgical technique.Although, it was reported that the instruments were checked outside of the patient, and no problem was found.Based on the information provided, the surgeon suspected the drop was damaged while inserting the nail inside of the patient.The impact to the patient beyond the femoral neck mal-reduction and the greater than 30-minutes surgical delay cannot be concluded since the findings/outcome of the reported unspecified intervention three days later to address this issue were not provided.Therefore, no further clinical/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 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 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.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.
Additional Manufacturer Narrative
H10: additional information in a2, b5.H11: corrected information in e1 and h6 (health effect - impact code).
Event or Problem Description
It was reported that, during the osteosynthesis surgery performed on (b)(6) 2022, the surgeon could not place the 6.4 solid hip screws in the nail.As reported, when passing the drill bit through the tan/fan radilucent drop, it would not target the nail correctly.The surgeon questioned the correct calibration of the device.When the device was checked outside the patient, it was working., therefore the surgeon suspected that the drop was damaged while inserting the nail in the patient.As no other option was available at the time, the surgeon completed the procedure using the same devices resulting in a femoral neck mal-reduction and a surgical delay greater than 30 minutes.The patient underwent an unspecified intervention to address the issue on (b)(6) 2022.

• Brand Name: TAN/FAN RADILUCENT DROP
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• 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: 15495975
• Report Number: 1020279-2022-04199
• Device Sequence Number: 5171181
• Product Code: HSB
• UDI-Device Identifier: 03596010604880
• UDI-Public: 03596010604880
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K122170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/21/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71631022
• Device Catalogue Number: 71631022
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2022
• Supplement Date Received by Manufacturer: 10/06/2022; 10/20/2022
• Initial Report FDA Received Date: 09/28/2022
• Supplement Report FDA Received Date: 10/10/2022; 10/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Female