MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 20CM 130D; NAIL, FIXATION, BONE

Catalog Number	71675386
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/28/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient went for a mandatory clinic check up and surgeon request a x-ray for the patient to see how the fracture is healing.Noted from the x-ray that the compression screw is backing out whereas the top screw is still in intact.According to surgeon, patient is walking in awkward posture.No pain so far.Compression screw back out of 1 cm.
Additional Manufacturer Narrative
The associated device was not returned as it remains implanted.Our medical investigation determined that based on the very limited information, the root cause for the screw ¿backing out¿ cannot be concluded at this time.A provided x-ray reveals the compression screw is ¿backing out¿ and the lag screw may be protruding further from the nail as well or this may be slight rotation of the images and can¿t be concluded.The fracture shows some coalescence but not complete healing in the approximate 2 ½ months.It is further reported, that the patient has no pain but is walking in an ¿awkward posture¿.No patient specific information has been forthcoming with this complaint and the nail and screws remain in situ at this time.It is unknown if the optional cannulated set screw was used.Should any relevant clinical/medical information become available this complaint can be re-assessed.A review of manufacturing records did not reveal any deviations that could have contributed to the reported issue.We have not had any previous complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.If additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: INTERTAN 10S 10MM X 20CM 130D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7355630
• Report Number: 1020279-2018-00362
• Device Sequence Number: 1393340
• Product Code: JDS
• UDI-Device Identifier: 00885556343692
• UDI-Public: 00885556343692
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2018

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: 71675386
• Device Lot Number: 17DM16757
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/28/2018
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 05/04/2018
• 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: Other; Required Intervention