MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.5MM LCK TUBULAR PL 6H 82MM; PLATE, FIXATION, BONE

Catalog Number	71809006
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/02/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a serious has occured.The patient had forearm plates done, he reported plate broke.Cause is unknown.
Additional Manufacturer Narrative
The associated complaint devices were not returned.The clinical/medical team concluded, the radiological imaging report dated 07/31/2018 (approximately 8 weeks post orif) noted ¿the plate and screw fixation of the ulnar bone demonstrates fracturing of the mid plate.This is associated with angulation of the distal bony fragment and non-union¿.The provided undated / unidentified ap/lat images support the fractured ulnar plate.No revision surgery has been performed yet, as it was communicated that the surgeon wants to wait for healing prior to removal.No further clinically relevant supporting documentation was provided for inclusion in this medical investigation.In conclusion: both the radiological report and electronic copy of the ap/lat images support the complaint of a broken ulnar plate, however, immediate post-op images were not available for comparison.The root cause of the ulnar plate fracture could not definitively be determined based on this limited information.Early weight-bearing prior to full bony-union is a known cause of hardware failure and cannot be ruled out as a contributing factor.The patient impact beyond probable discomfort, delayed healing of the ulnar bone, and future hardware removal with an expected brief post-operative rehabilitation cannot be determined.No further medical assessment can be rendered at this time.A review of the production documentation for the corresponding products 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 batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: 3.5MM LCK TUBULAR PL 6H 82MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8020596
• Report Number: 1020279-2018-02296
• Device Sequence Number: 13863130
• Product Code: HRS
• UDI-Device Identifier: 03596010523211
• UDI-Public: 03596010523211
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K033669
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2019

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: 71809006
• Device Lot Number: 17LT94828
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/02/2018
• Supplement Date Received by Manufacturer: 10/02/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 05/04/2019
• 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