MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII LONG I/M ROD 16 INCH; PROSTHESIS,K, PALL/FMRTIBIAL,SMI-CTRD, UCMNTD, PRS, COAD, POLYM/METAL/POLYM

Catalog Number	71440004
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the rod was broken.The instrument broke inside the patient.S&n backup device available and the procedure was delayed less than 30 minutes due to this incident.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device is heavily worn with many nicks, gouges and burrs on the cutting edges.The device was manufactured in 2001 and exhibits signs of extensive wear/usage.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 the device or 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.Credit will be issued for the device.

• Brand Name: GII LONG I/M ROD 16 INCH
• Common Device Name: PROSTHESIS,K, PALL/FMRTIBIAL,SMI-CTRD, UCMNTD, PRS, COAD, POLYM/METAL/POLYM
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8293014
• Report Number: 1020279-2019-00357
• Device Sequence Number: 1598235
• Product Code: MBH
• UDI-Device Identifier: 03596010213723
• UDI-Public: 03596010213723
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• 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
• Report Date (Section B): 09/25/2019

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 Catalogue Number: 71440004
• Device Lot Number: 01EM04238
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/02/2019
• Supplement Date Received by Manufacturer: 01/02/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1