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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LINCOTEK MEDICAL LLC SUTURE PASSER NEEDLE

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LINCOTEK MEDICAL LLC SUTURE PASSER NEEDLE Back to Search Results
Model Number 3910-900-091
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/27/2021
Event Type  malfunction  
Manufacturer Narrative
Date product received: product was not available for return. Device identification: where product was not returned the device could not be identified other than what is listed in the complaint. Device history record review: the device history record for this manufacture lot was reviewed. There were no non-conformances listed in the record. Sample needles were fatigue tested from this manufacture lot and show with 95% confidence that 99. 9% of the lot will pass a minimum of 24 cycles. Visual inspection: where the product was not returned a visual inspection was not performed. Functional inspection: where the product was not returned a functional inspection was not performed. Root cause(s): where the product was not returned an exact root cause could not be confirmed. It is possible the needle came in contact with bone or was being passed through thicker tissue which may have contributed to the breakage. The information provided with the complaint is minimal and does not identify a root cause. This is a known failure mode addressed in the risk management file for this product, and does not exceed expected occurrence rates. Occurrence rates are monitored for trends.
 
Event Description
It is reported that the end of the needle broke off in tendon during repair. A second needle was used to complete the surgery. No revision surgery required, tip imbedded deep in tendon; see intake email for more details. Surgeon; (b)(6). Country of event: (b)(6).
 
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Brand NameSUTURE PASSER NEEDLE
Type of DeviceSUTURE PASSER NEEDLE
Manufacturer (Section D)
LINCOTEK MEDICAL LLC
867 west 400 north
logan UT 84321
MDR Report Key12636843
MDR Text Key281659644
Report Number3004086872-2021-00001
Device Sequence Number1
Product Code GAB
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 10/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/12/2021
Device Model Number3910-900-091
Device Lot Number1942273
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

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