MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-TAN 0MM SET SCREW; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	71642936
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/12/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient suffered pain "implaint" shift and a revision surgery was performed to relocate lag screws.Set screw could not be removed due to stripped head.Inferior screw replaced.No delay, additional injuries or back up reported.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.One of the attachment posts fractured off the device and was returned.The device was manufactured in 2013 and exhibits signs of extensive wear/usage.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: META-TAN 0MM SET SCREW
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8028280
• Report Number: 1020279-2018-02297
• Device Sequence Number: 19215044
• Product Code: HSB
• UDI-Device Identifier: 00885556343494
• UDI-Public: 00885556343494
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K092748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2019

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 Expiration Date: 01/26/2026
• Device Catalogue Number: 71642936
• Device Lot Number: 16AM20198
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2018
• Supplement Date Received by Manufacturer: 10/12/2018; 10/12/2018
• Initial Report FDA Received Date: 11/01/2018
• Supplement Report FDA Received Date: 06/05/2019; 07/03/2019
• 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: 71642680 / 15LT61395; 71642680 / 15LT61395; 71649632 / 17ET86910; 71649632 / 17ET86910
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention