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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. PASSING PIN 2.4MM PASSER

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SMITH & NEPHEW, INC. PASSING PIN 2.4MM PASSER Back to Search Results
Model Number 014395
Device Problem Break (1069)
Patient Problem Injury (2348)
Event Date 06/22/2020
Event Type  Injury  
Event Description
It was reported that during an acl surgery, when the surgeon was drilling through the tibia the tip of the 2. 4mm passing pin broke off. No significant delay was reported (<5 minutes). Smith and nephew back up device was used to complete the surgery and the broken pieces were removed by using tweezers. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
 
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Brand NamePASSING PIN 2.4MM
Type of DevicePASSER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
Manufacturer (Section G)
SMITH & NEPHEW, INC.
130 forbes blvd.
mansfield MA 02048
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10272071
MDR Text Key198752833
Report Number1219602-2020-01027
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K920621
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number014395
Device Catalogue Number014395
Device Lot Number2031265
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/14/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/14/2020 Patient Sequence Number: 1
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