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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRUEPASS NEEDLE SINGLE PACK STERILE BX 5; ACCESSORIES, ARTHROSCOPIC

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SMITH & NEPHEW, INC. TRUEPASS NEEDLE SINGLE PACK STERILE BX 5; ACCESSORIES, ARTHROSCOPIC Back to Search Results
Catalog Number 72203793
Device Problems Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Component Missing (2306)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/14/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that during a shoulder scope the truepass device fell on the floor.The device was cleaned and soaked.The surgeon attempted to use it again, but the needle had broke off.The surgeon looked inside of the joint and all around the area, but the tip was not found.The patient was sent to x-ray to verify if a piece was left in the patient.
 
Manufacturer Narrative
Examination was not possible, as the device will not be returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event without the return of the device.Further investigation is not warranted at this time.
 
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Brand Name
TRUEPASS NEEDLE SINGLE PACK STERILE BX 5
Type of Device
ACCESSORIES, ARTHROSCOPIC
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 w. william cannon
austin, TX 78735
5123585706
MDR Report Key6066195
MDR Text Key59030270
Report Number1219602-2016-01219
Device Sequence Number1
Product Code NBH
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number72203793
Device Lot Number50608680
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/14/2016
Initial Date FDA Received10/31/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/27/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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