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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 16MM; SCREW, FIXATION, BONE

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ARTHREX, INC. LO-PRO SCRW,TI,3.5MMX 16MM; SCREW, FIXATION, BONE Back to Search Results
Model Number LO-PRO SCRW,TI,3.5MMX 16MM
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/17/2020
Event Type  Injury  
Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.
 
Event Description
It was reported that during a distal radius orif procedure, upon final insertion of the ar-8935-16 (3.5 low profile screw), the head of the screw broke off of the screw body.All of the screw body remained in the patient (approximately 16 mm).This occurred during the final seating of the screw.The surgeon used and ar-8916-14, 1.7mm drill bit to prep the bone socket.The patient was reported to have good bone quality.Patient was a (b)(6) male.After the screw head broke off and the screw body remained, it was reported that the two other distal 3.5 cortical screws had good purchase and the surgeon was confident enough in the construct to proceed with the case.The case was completed.
 
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Brand Name
LO-PRO SCRW,TI,3.5MMX 16MM
Type of Device
SCREW, FIXATION, BONE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer (Section G)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
Manufacturer Contact
vik bajnath
8009337001
MDR Report Key10218064
MDR Text Key197210778
Report Number1220246-2020-01940
Device Sequence Number1
Product Code HWC
UDI-Device Identifier00888867050426
UDI-Public00888867050426
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K143614
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other
Type of Report Initial
Report Date 07/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberLO-PRO SCRW,TI,3.5MMX 16MM
Device Catalogue NumberAR-8935-16
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 06/18/2020
Initial Date FDA Received07/01/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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