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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. NONRIM SPEED PIN 65 STERILE PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS Back to Search Results
Catalog Number 74013480
Device Problem Flaked (1246)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/06/2019
Event Type  malfunction  
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.
 
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 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.
 
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Brand NameNONRIM SPEED PIN 65 STERILE
Type of DevicePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key9340368
MDR Text Key168571592
Report Number1020279-2019-04071
Device Sequence Number1
Product Code MBL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K113848
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number74013480
Device Lot Number18BNX0101
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/23/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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