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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW ORTHOPAEDICS AG TC-PLUS PRIMARY TIBIAL CUTTING BLOCK ADJ INSTRUMENT, CUTTING, ORTHOPEDIC

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SMITH & NEPHEW ORTHOPAEDICS AG TC-PLUS PRIMARY TIBIAL CUTTING BLOCK ADJ INSTRUMENT, CUTTING, ORTHOPEDIC Back to Search Results
Catalog Number 75018727
Device Problem Corroded (1131)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/21/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during a tka, the tibial cutting block shows metal abrasion and sharp edges at the saw slot. The procedure was successfully completed without delay using a back-up device. No patient injury or other complications were reported.
 
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Brand NameTC-PLUS PRIMARY TIBIAL CUTTING BLOCK ADJ
Type of DeviceINSTRUMENT, CUTTING, ORTHOPEDIC
Manufacturer (Section D)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau CH-50 00
SZ CH-5000
Manufacturer (Section G)
SMITH & NEPHEW ORTHOPAEDICS AG
schachenallee 29
aarau CH-50 00
SZ CH-5000
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key11023071
MDR Text Key222396071
Report Number9613369-2020-00262
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number75018727
Device Lot NumberA71847
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/21/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/27/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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