MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LAG/COMP SCREW KIT 90/85; NAIL, FIXATION, BONE

Model Number	71677090
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Failure of Implant (1924); Insufficient Information (4580)
Date of Event	06/18/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after an internal fixation was performed on (b)(6) 2022, the patient experienced early compression, causing the lag/comp screw kit 90/85 to begin pulling from the head of the femur.This event was treated by a revision surgery on (b)(6) 2022, in which the interstrain 10s 10mm x 18cm 130d was removed.During the removal, the trigen low profile screw 5.0mm x 30mm stripped out.Several techniques were used for the removal, including driving the screw to the far cortex, fracturing the femur.Current health status of patient is unknown.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the devices were not returned for evaluation and the reported event could not be confirmed according to the provided photos.The clinical/medical investigation concluded that, per the complaint details, we are currently unable to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.Per the instructions for use for the intramedullary nail system, ¿it reveals in the preoperative planning section that correct surgical technique is essential to a successful outcome.¿ based on the information provided in the complaint, this adverse event was treated with a revision surgery two days later.According to the report, several techniques were used for the removal including driving the screw to the far cortex, fracturing the femur.Four undated, unlabeled photo images that support the removal of the devices were provided for review, one of the intertan 10s 10mm x 18cm 130d, one of the lag/comp screw kit 90/85 and two photos of the trigen low profile screw 5.0mm x 30mm.The impact to the patient beyond the reported revision could not be confirmed nor concluded due to lack of information.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this cause would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for intramedullary nail system revealed that correct surgical technique is essential to a successful outcome has been identified as preoperative planning.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 these products and event.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.The contribution of the devices to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Should the devices 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
Additional information: d9.H3, h6: visual inspection of the device revealed that the screw of the kit is stripped.The reported event could be confirmed.The clinical/medical investigation concluded that, per the complaint details, we are currently unable to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.Per the instructions for use for the intramedullary nail system, ¿it reveals in the preoperative planning section that correct surgical technique is essential to a successful outcome.¿ based on the information provided in the complaint, this adverse event was treated with a revision surgery two days later.According to the report, several techniques were used for the removal including driving the screw to the far cortex, fracturing the femur.Four undated, unlabeled photo images that support the removal of the devices were provided for review, one of the intertan 10s 10mm x 18cm 130d, one of the lag/comp screw kit 90/85 and two photos of the trigen low profile screw 5.0mm x 30mm.The impact to the patient beyond the reported revision could not be confirmed nor concluded due to lack of information.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this cause would be re-assessed.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for intramedullary nail system revealed that correct surgical technique is essential to a successful outcome has been identified as preoperative planning.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 these products and event.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.Potential factors that contribute to the reported event include but not limited to surgical technique used, size of device or user/procedural variance.The contribution of the device to the reported incident could be corroborated as it was required a revision surgery to treat this event.Based on this investigation, the need for corrective action is not indicated.Should the devices 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.H3, h6, h10.

• Brand Name: LAG/COMP SCREW KIT 90/85
• Common Device Name: NAIL, 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: 14974285
• Report Number: 1020279-2022-03275
• Device Sequence Number: 17559389
• Product Code: JDS
• UDI-Device Identifier: 03596010563309
• UDI-Public: 03596010563309
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2022

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: 71677090
• Device Catalogue Number: 71677090
• Device Lot Number: 22CM19374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2022
• Supplement Date Received by Manufacturer: 08/12/2022; 12/02/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 08/16/2022; 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: INTERTAN 10S 10MM X 18CM 130D, LOT#:21JM06374.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown