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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION HENRY SCHEIN HS 3-0 PGA UNDYED BR 18"/45CM PC31

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SURGICAL SPECIALTIES CORPORATION HENRY SCHEIN HS 3-0 PGA UNDYED BR 18"/45CM PC31 Back to Search Results
Model Number 900-4421
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/30/2017
Event Type  malfunction  
Manufacturer Narrative
-method: the actual product involved with the incident was discarded. No samples were returned for evaluation to date. -results/conclusions: no samples were returned for review. Relevant portions of the device history record were reviewed. The product from this finished good lot and all of the component lots met current (b)(4). Requirements throughout the incoming, manufacturing and the final inspection processes. No inventory is available for the finished good lot reported. -without receiving samples to review/test, receiving detailed information regarding the pre-operative preparation of the device or the surgeon's technique, a definitive root cause for the needle breaking during use cannot be determined at this time. Reference:reference (b)(4). - henry schein reference #(b)(4). - item #900-4421 henry schein 3-0 pga undyd br 18"/45cm pc31 , lot mbcq750.
 
Event Description
It was reported by the customer that the needle broke during a cyst excision on the neck. An xray was required to locate the needle segment retained in the wound. The piece was removed without injury or further incident.
 
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Brand NameHENRY SCHEIN
Type of DeviceHS 3-0 PGA UNDYED BR 18"/45CM PC31
Manufacturer (Section D)
SURGICAL SPECIALTIES CORPORATION
corredor tijuana-rosarito 2000
24702-b, ejido francisco villa
tijuana 22235
MX 22235
Manufacturer (Section G)
SURGICAL SPECIALTIES CORPORATION
corredor tijuana-rosarito 2000 #24702b
ejido francisco villa
tijuana 22235
MX 22235
Manufacturer Contact
kelly knappenberger
1100 berkshire blvd.
ste 308
reading, PA 19608
MDR Report Key6991470
MDR Text Key91229787
Report Number3010692967-2017-00012
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Reporter Occupation
Type of Report Initial
Report Date 04/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/31/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/29/2021
Device Model Number900-4421
Device Catalogue Number900-4421
Device Lot NumberMBCQ750
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 Received04/11/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/29/2016
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: 10/31/2017 Patient Sequence Number: 1
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