MAUDE Adverse Event Report: SMITH & NEPHEW, INC. NONRIM SPEED PIN 65 STERILE; PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS

Catalog Number	74013480
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The associated devices were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure mode.The devices had numerous score marks on the shaft where material had been removed, making the laser markings barely visible.The devices were manufactured in 2018 and exhibits signs of extensive wear/ usage.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.A visual inspection of the returned devices confirmed the stated failure mode.The devices had numerous score marks on the shaft where material had been removed, making the laser markings barely visible.The devices were manufactured in 2018 and exhibits signs of extensive wear/ usage.A review of complaint history did not reveal additional complaints for the listed batch.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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.Credit will be issued for the devices.
Event or Problem Description
It was reported that during surgery, after the distal femoral cutting, there were the shaving substances.The marking of the pin was damaged and vanished, so the shavings were considered they were from the pin.This issue was found after screwing the pin and did not affect the surgery.Everything was removed from patient.Delay less than 30 minutes and no injury.

• Brand Name: NONRIM SPEED PIN 65 STERILE
• Common Device Name: PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9340507
• Report Number: 1020279-2019-04072
• Device Sequence Number: 14166213
• Product Code: MBL
• UDI-Device Identifier: 00885556070925
• UDI-Public: 00885556070925
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2019

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: 74013480
• Device Lot Number: 18BNX0101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 11/19/2019
• Supplement Report FDA Received Date: 11/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1