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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. LO-PRO LOCK SCRW,SS 3.5X 12MM; SCREW, FIXATION, BONE
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ARTHREX, INC. LO-PRO LOCK SCRW,SS 3.5X 12MM; SCREW, FIXATION, BONE Back to Search Results
Model Number LO-PRO LOCK SCRW,SS 3.5X 12MM
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 01/25/2021
Type of Reportable Event Malfunction
Additional 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 or Problem Description
It was reported that during a dex procedure, the ar-8835l-12, screw rolled into the locking head with plate and could not be used.All fragments were removed and the case was completed by using another ar-8835l-12 without further issue.
 
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Brand Name
LO-PRO LOCK SCRW,SS 3.5X 12MM
Common Device Name
SCREW, FIXATION, BONE
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key11358081
Report Number1220246-2021-02610
Device Sequence Number16987314
Product Code HWC
UDI-Device Identifier00888867047532
UDI-Public00888867047532
Combination Product (Y/N)N
Initial Reporter CountryCI
PMA/510(K) Number
K143614
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date (Section B) 02/22/2021
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? Yes
Operator of Device Health Professional
Device Model NumberLO-PRO LOCK SCRW,SS 3.5X 12MM
Device Catalogue NumberAR-8835L-12
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 02/04/2021
Initial Report FDA Received Date02/22/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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