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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TENSION GAUGE GAUGE, DEPTH

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SMITH & NEPHEW, INC. TENSION GAUGE GAUGE, DEPTH Back to Search Results
Catalog Number 00578907100
Device Problems Break (1069); Entrapment of Device (1212); Fracture (1260)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 04/26/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Please review attached for investigation results. (b)(4).
 
Event Description
Upon unicompartmental implantation the device was inserted to provide compression as the cement hardened. The device broke in two. Upon breaking the smaller piece became entrapped in the posterior capsule. The piece could not be retrieved so the unicompartmental knee was explanted, the broken piece was extracted and the unicompartmental knee was converted to a legion tka. Surgery was extended due to this.
 
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Brand NameTENSION GAUGE
Type of DeviceGAUGE, DEPTH
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
markus poettker
schachenallee 29
aarau 05001
SZ   05001
MDR Report Key6584047
MDR Text Key106888554
Report Number1020279-2017-00364
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number00578907100
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/05/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2017
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

Patient Treatment Data
Date Received: 05/23/2017 Patient Sequence Number: 1
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