MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 10 X 36 130 D TAN RT ROSE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71648236
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the final phase of the procedure, the proximal cap did not join to nail.The indicated procedure was done, but these did not adapt properly to the nail, therefore, another cap was opened but this also failed, the patient was left without a cap.It is unknown if the problem is associated with the plugs or the nail.The patient's health condition is stable.Delay 30 minutes -1 hour reported.
Additional Manufacturer Narrative
The associated complaint devices were not returned.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.Without the actual device involved our investigation cannot proceed.If the device or new information is received in the future, the complaints can be re-opened.No further actions are being taken at this time.

• Brand Name: 10 X 36 130 D TAN RT ROSE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9318098
• Report Number: 1020279-2019-04016
• Device Sequence Number: 2360278
• Product Code: HSB
• UDI-Device Identifier: 03596010501141
• UDI-Public: 03596010501141
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K040462
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2024
• Device Catalogue Number: 71648236
• Device Lot Number: 14JM16974
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 12/12/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 12/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1