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

Catalog Number	71677090
Medical Device Problem Codes	Material Disintegration (1177); Defective Device (2588)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	05/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an intertan case, as the compression screw was being inserted under the lag screw, once compression was being applied, the screw would tighten and then bounce backwards.The screw was removed from the patient, and inspected to see small metal shavings on the threads of the screw.Both screws were removed and replaced with a new interlocking screw kit, which functioned as normal and compressed the fracture.A delay was presented less or equal to 30 minutes.It is unknown the state of the patient.
Additional Manufacturer Narrative
Smith & nephew is submitting this report pursuant to the provisions of 21 c.F.R.Part 803.This report may be based upon information which smith & nephew has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, or its employees, that the report constitutes an admission that the device, smith & nephew or its employees caused or contributed to the potential event described in this report.
Event or Problem Description
It was reported that during an intertan case, as the compression screw was being inserted under the lag screw, once compression was being applied, the screw would tighten and then bounce backwards.The screw was removed from the patient, and inspected to see small metal shavings on the threads of the screw.Both screws were removed and replaced with a new interlocking screw kit, which functioned as normal and compressed the fracture.A delay was presented less or equal to 30 minutes.It is unknown the state of the patient.
Event or Problem Description
It was reported that during an intertan case, as the compression screw was being inserted under the lag screw, once compression was being applied, the screw would tighten and then bounce backwards.The screw was removed from the patient, and inspected to see small metal shavings on the threads of the screw.Both screws were removed and replaced with a new interlocking screw kit, which functioned as normal and compressed the fracture.A delay was presented less or equal to 30 minutes.It is unknown the state of the patient.
Additional Manufacturer Narrative
Smith & nephew, inc.Is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based upon information which smith & nephew, inc.Has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, smith & nephew, inc., or its employees, that the report constitutes an admission that the device, smith & nephew, inc., or its employees caused or contributed to the potential event described in this report.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms this complaint from australia reports that during the primary surgery a compression screw would not maintain the compression.¿both screws were removed and replaced with a new interlocking screw kit, which functioned as normal and compressed the fracture.A delay was reported of less than or equal to 30 minutes.¿ the impact to the patient cannot be determined with the information provided.Smith and nephew has not received the adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.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 risk management files and instructions for use found that the reported failure was documented appropriately.Possible probable cause could include but not limited the user error.Based on this investigation, the need for corrective action is not indicated.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further investigation warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LAG/COMP SCREW KIT 90/85
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis; memphis TN 38116
• MDR Report Key: 10105413
• Report Number: 1020279-2020-01929
• Device Sequence Number: 14207434
• Product Code: JDS
• UDI-Device Identifier: 03596010563309
• UDI-Public: 3596010563309
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/05/2021

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 Catalogue Number: 71677090
• Device Lot Number: 19MM09155
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/03/2020
• Initial Date Received by Manufacturer: 05/03/2020
• Supplement Date Received by Manufacturer: 05/03/2020; 05/03/2020; 02/05/2021
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 06/01/2020; 09/30/2020; 03/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention