MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10MM X 34CM 130D RT; NAIL, FIXATION, BONE

Catalog Number	71675266
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Code	Intraoperative Pain (2662)
Date of Event	07/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a revision surgery in which the compression screw backed off three months post-op.They had to remove the nail because the prominent screw caused pain.All pieces were removed.
Additional Manufacturer Narrative
The affected trigen intertan nail was not returned for evaluation.No clinical relevant documents were provided to conduct a thorough medical assessment, thus no medical assessment is warranted at this time.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.Without the return of the actual product involved, our investigation of this report is inconclusive.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.Should additional information be received, the complaint will be reopened.
Additional Manufacturer Narrative
The associated lag compression screw kit, trigen internal hex captured screw and intertan nail were returned and evaluated.A lab analysis conducted during this investigation indicated that the burnishing of the nail and screws is caused by motion or rotation in vivo or during insertion/removal.A functional test was performed and the lag screw can only translate medially due to clockwise rotation of compression screw.The exact cause of this potential rotation is unknown.It can be caused by a number of factors, including but not limited to interaction with soft tissues.Based on the analysis conducted, the exact cause of the reported failure was not able to be determined.No material deviations were observed in this investigation.Our investigation including a review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A clinical evaluation noted that a review of the referenced documents did not add any additional value or did not change the previous closure statement.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: INTERTAN 10MM X 34CM 130D RT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7737678
• Report Number: 1020279-2018-01455
• Device Sequence Number: 805439
• Product Code: JDS
• UDI-Device Identifier: 03596010560896
• UDI-Public: 03596010560896
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2019

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 Catalogue Number: 71675266
• Device Lot Number: 15JM01732
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 07/20/2018; 07/20/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 10/26/2018; 03/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71677095/15MM05252; UNKNOWN TRAUMA IMPLANT/UNKNOWN
• Outcome Attributed to Adverse Event: Required Intervention