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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARCUS MEDICAL, LLC PTS PASSER NEEDLE; SUTURE PASSER NEEDLE
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PARCUS MEDICAL, LLC PTS PASSER NEEDLE; SUTURE PASSER NEEDLE Back to Search Results
Model Number 11234
Device Problems Material Fragmentation (1261); Mechanical Problem (1384); Use of Device Problem (1670); Failure to Fire (2610); Material Integrity Problem (2978); No Apparent Adverse Event (3189)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2021
Event Type  malfunction  
Event Description
An unknown patient had a shoulder arthroscopy surgical procedure that utilized the pts passer with single use needle and several parcus medical suture anchors.During the procedure, it was noted that the pts passer was not passing the suture tape effectively.Eventually, the suture tape was passed through the target tissue and the procedure concluded.Following the procedure, it was identified that the tip of the single use nitinol needle had broken often.At this time, it is unclear when the needle tip was broken and where the loose body ended up.
 
Event Description
An unknown patient had a shoulder arthroscopy surgical procedure that utilized the pts passer with single use needle and several parcus medical suture anchors.During the procedure, it was noted that the pts passer was not passing the suture tape effectively.Eventually, the suture tape was passed through the target tissue and the procedure concluded.Following the procedure, it was identified that the tip of the single use nitinol needle had broken offen.At this time, it is unclear when the needle tip was broken and where the loose body ended up.Update 16jul21: parcus medical was able to get in touch with the surgeon performing the arthroscopy.The surgeon indicated that he was aware of what had happened during the procedure and insisted that the loose body had been removed from the patient during the surgery.He indicated that a "loose body grasper" had been used and recalled seeing the fragment on the mayo stand in the or.When asked if this could have been from another surgery that he had done that day and he assured me that it was not possible.He then went on to explain why he thought that the needle wasn't passing smoothly.The doctor reaffirmed that nothing had been left behind in the patient and that the case had concluded without issue or injury to the patient.
 
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Brand Name
PTS PASSER NEEDLE
Type of Device
SUTURE PASSER NEEDLE
Manufacturer (Section D)
PARCUS MEDICAL, LLC
6423 parkland dr
sarasota FL 34243 4003
MDR Report Key12178590
MDR Text Key261902128
Report Number3007319107-2021-00009
Device Sequence Number1
Product Code HWQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Remedial Action Notification
Type of Report Initial,Followup
Report Date 07/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number11234
Device Catalogue Number11234
Device Lot Number15477
Was Device Available for Evaluation? No
Date Manufacturer Received06/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
REUSABLE PTS PASSER HAND PIECE; REUSABLE PTS PASSER HAND PIECE; VARIOUS PARCUS MEDICAL SUTURE ANCHORS.; VARIOUS PARCUS MEDICAL SUTURE ANCHORS.; REUSABLE PTS PASSER HAND PIECE; VARIOUS PARCUS MEDICAL SUTURE ANCHORS.
Patient Outcome(s) Other;
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