MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN LAG/COMP KIT 90/85; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	71642690
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, during surgery of nail removal (planned surgery), when removing's the lag screw, the tip of the two (2) meta-tan lag screw driver were broken.Using other tool screw extractor size 1, the surgery was completed, but also it was broken when it was removed from the explanted lag screw.Device inside the patient.Pieces fell inside the patient and it is unknown if/how the pieces were extracted.The procedure was completed using a s+n back-up device.Surgery was 30 min delayed.Patient was not harmed.No further information is available.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
H6: health effect - impact code.Section h3, h6: the associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device was found to be broken along the head of the lag screw, rendering the device inoperative.The clinical/medical evaluation concluded that based on a review of the information provided, we are unable to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.According to the visual inspection, the provided photo indicated the two fractured pieces of screwdriver, and the lag screw were returned for evaluations.However, there are two additional fragments seen in the photo that could not be identified.Without the return of extractor tool for evaluation we are unable to determine if the two unidentified fragments seen in the photo were fragments from the broken extractor tool.The non-implantable extractor tools are manufactured and intended as externally communicating surgical devices and are not approved for long-term internal tissue exposure and long-term implantation data is not available.If any of the extractor tool fragments were retained inside the patient, their location is unknown.Therefore, we cannot make definitive conclusions on the impact of the non-implantable foreign bodies.Although, we cannot rule out the potential for micro-motion/migration, local skin irritation and pain from the retained fragments.It was reported the surgeon was able to complete the procedure with a s&n back-up device with a 30-minute delay.Should any additional relevant medical information be provided, this case would be re-assessed.No further clinical/medical assessment is warranted at this time.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 manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use document revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.A contribution of the device to the reported event could be corroborated as the device shows signs of damage/wear.The probable cause could be but is not limited to excessive force or loading.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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: META-TAN LAG/COMP KIT 90/85
• 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: 15245681
• Report Number: 1020279-2022-03715
• Device Sequence Number: 5807931
• Product Code: HSB
• UDI-Device Identifier: 00885556132975
• UDI-Public: 00885556132975
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K092748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2022

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: 71642690
• Device Catalogue Number: 71642690
• Device Lot Number: 19DT20309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 09/16/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 09/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2019
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male