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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCR SFTSLK 2.0 PKG.8X25 STER; SCREW, FIXATION, BONE
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SMITH & NEPHEW, INC. SCR SFTSLK 2.0 PKG.8X25 STER; SCREW, FIXATION, BONE Back to Search Results
Catalog Number 7207260
Device Problem Device Expiration Issue (1216)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/15/2017
Event Type  malfunction  
Manufacturer Narrative
Device investigation narrative - device is not being returned for evaluation.Per the device ifu under warnings ¿do not use after the expiration date¿.Further investigation is not warranted at this time.(b)(4).
 
Event Description
A screw was used successfully to complete an acl procedure.However, it was later discovered that the expiry date on the screw in question had passed.
 
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Brand Name
SCR SFTSLK 2.0 PKG.8X25 STER
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes boulevard
mansfield MA 02048
Manufacturer Contact
jim gonzales
7000 west william cannon drive
austin, TX 78735
MDR Report Key6800651
MDR Text Key83098166
Report Number1219602-2017-00939
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K921481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation Health Professional
Type of Report Initial
Report Date 08/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2017
Device Catalogue Number7207260
Device Lot Number50423171
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/19/2017
Date Device Manufactured06/21/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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