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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. REAMER, LOW PROFILE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
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ARTHREX, INC. REAMER, LOW PROFILE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT Back to Search Results
Model Number REAMER, LOW PROFILE
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 10/22/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.
 
Event or Problem Description
It was reported that the tip of the reamer broke in the shoulder bone during a proximal biceps tenodesis.The surgeon had predrilled with 3.2 drill.The tip was not retrieved from the patient; the case was completed.
 
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Brand Name
REAMER, LOW PROFILE
Common Device Name
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
Manufacturer (Section D)
ARTHREX, INC.
1370 creekside boulevard
naples FL 34108 1945
MDR Report Key8063894
Report Number1220246-2018-00737
Device Sequence Number1947018
Product Code LXH
UDI-Device Identifier00888867016682
UDI-Public00888867016682
Combination Product (Y/N)N
Initial Reporter StateIL
Initial Reporter CountryUS
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/13/2018
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
Operator of Device Health Professional
Device Expiration Date05/31/2022
Device Model NumberREAMER, LOW PROFILE
Device Catalogue NumberAR-1407LP
Device Lot Number10142182
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/22/2018
Initial Report FDA Received Date11/13/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
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