MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL NAIL CAP SET SCREW 0MM; OXIMETER, TISSUE SATURATION

Model Number	71656000
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the nail was placed correctly and at the time of securing with the plug, this didn´t fit with the nail.It was decided to leave the patient without a closure cap.No damage to patient occurred.Delay greater than 30 min.
Additional Manufacturer Narrative
The device, intended for use in treatment was not returned for evaluation.Without the actual product, product evaluation could not be performed and complaint could not be confirmed.The device was manufactured in 2018.According to clinical/medical investigation , no sufficient documentation was provided to support this event.Without supporting clinical/medical documents, a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed.No impact to the patient has been reported.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review for the listed part revealed no prior complaints for the listed failure with same batch number.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: META-NAIL NAIL CAP SET SCREW 0MM
• Common Device Name: OXIMETER, TISSUE SATURATION
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9395856
• Report Number: 1020279-2019-04221
• Device Sequence Number: 2790546
• Product Code: MUD
• UDI-Device Identifier: 03596010585417
• UDI-Public: 03596010585417
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K061619
• 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): 05/13/2020

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 Model Number: 71656000
• Device Catalogue Number: 71656000
• Device Lot Number: 18FM21426
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 12/02/2019
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 80