MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII NP FIN-STEM PUNCH S5-6; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Catalog Number	71449995
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that dr split tibia, questioning if the tibia punches were so dull that caused the injury.Backup was available.Is unknown if a delay occurred during the surgery.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure mode.The cutting edges of the devices were damaged/ dull, rendering the devices inoperable.The devices were manufactured in 2006 and 2007 and exhibit signs of extensive wear/usage.A review of complaint history did not reveal additional complaints for the listed batches.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.The clinical/ medical team concluded that without the requested supporting clinical documents a thorough medical investigation cannot be rendered.However, the visual inspection of the returned devices confirmed the stated failure mode.Should any additional relevant clinical information be provided this complaint will be re-assessed.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: GII NP FIN-STEM PUNCH S5-6
• Common Device Name: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8448634
• Report Number: 1020279-2019-01159
• Device Sequence Number: 2887670
• Product Code: MBH
• UDI-Device Identifier: 03596010581730
• UDI-Public: 03596010581730
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2019

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: 71449995
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 05/12/2019
• 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: Hospitalization; Required Intervention