MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10S 10MM X 42CM 125D RIGHT; NAIL, FIXATION, BONE

Catalog Number	71675539
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	05/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the intertan nail was scheduled to be removed, and a blade plate implanted.The intertan had broken at the hole for the lag/compression screw, and the head of the compression screw was also broken off.The nail had failed because the patient had a hypertrophic non-union.The surgeon was unable to remove the broken compression screw because there is no instrumentation or technique for removing it that will spare enough of the femoral head and neck to allow for implantation of a blade plate.The surgeon elected stop the procedure and return the patient to the or two days later when he was prepared to preform a total hip arthroplasty.
Event or Problem Description
Further information determined the total hip arthroplasty was performed on (b)(6) 2017.
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see attached the results of our investigation.(b)(4).

• Brand Name: INTERTAN 10S 10MM X 42CM 125D RIGHT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6555335
• Report Number: 1020279-2017-00330
• Device Sequence Number: 1170430
• Product Code: JDS
• UDI-Device Identifier: 00885556345641
• UDI-Public: 00885556345641
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2017

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 Expiration Date: 07/21/2025
• Device Catalogue Number: 71675539
• Device Lot Number: 15GM15709
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: Not provided; 05/03/2017
• Initial Report FDA Received Date: 05/09/2017
• Supplement Report FDA Received Date: 05/10/2017; 09/28/2017
• 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: LAG SCREW PART# 71677095 LOT# 16FT72261
• Patient Age: 76 YR
• Patient Weight: 77