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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARTHREX, INC. 3.0X130MM FIBULA NAIL, LEFT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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ARTHREX, INC. 3.0X130MM FIBULA NAIL, LEFT ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number 3.0X130MM FIBULA NAIL, LEFT
Device Problems Fracture (1260); Labelling, Instructions for Use or Training Problem (1318); Use of Device Problem (1670); Failure to Align (2522)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/17/2019
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 during a primary percutaneous procedure that took place on (b)(6) 2019, the surgeon was attempting to put a sonoma 3. 5 x 55 ((b)(4) / lot: a17111705 ) screw into the ar-8973l-30-130 fibula nail (lot: 10297815), but the screw would not line up and the surgeon could not get the right trajectory. The surgeon was able to achieve good fixation without using the screw. The fibula nail was left implanted, and the case was completed successfully. The patient came in for a follow up visit on (b)(6) 2019 and during the follow-up visit it was discovered that the patient ambulated on the nail post-operatively and re-fractured their fibula. A revision/removal procedure took place on (b)(6) 2019, and was performed by the same surgeon at the same facility. During the revision procedure, the ar-8973l-30-130 was successfully removed. Upon removal, it was discovered that the device is labeled as an ar-8973l-30-130 (left) nail, but the device is actually a right nail. The nail was reinserted on the jig, and upon further investigation all holes lined up as a right nail. It was also discovered that the lot number etched on the device is different than the lot number that was on the original packaging (lot: 10297815). The lot number physically etched on the device is lot: 10286779. The rep confirmed no other arthrex parts were implanted during the revision procedure, and the case was completed. The rep stated that the discrepancy with the lot numbers, and incorrect part were not discovered/noticed during the primary procedure. The rep confirmed all arthrex parts that were implanted during the primary procedure were removed during the revision. The rep confirmed only the ar-8973l-30-130 is available to return for evaluation. The explanted screws were discarded. The following arthrex parts were implanted during the primary procedure: ar-8973ds // lot: 10293742 // qty. 1 (implant system used), ar-8973l-30-130 // lot: 10297815 // qty. 1, ar-8827l-14 // lot: unknown // qty. 1, ar-8827l-16 // lot: unknown // qty. 1, ar-8827l-22 // lot: unknown // qty. 1. Additional information received on (b)(6) 2019: the fibulock implant system (ar-8973ds) was used. This kit includes a 6. 2 distal reamer, a 3. 2 proximal reamer and the 2. 0 drill bit for distal screw fixation. The sonoma ((b)(4)) 2. 5 mm syndesmotic drill was also used to prepare the bone. The bone was of good quality (hard to medium) and no graft was utilized in the case.
 
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Brand Name3.0X130MM FIBULA NAIL, LEFT
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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 Key8739490
MDR Text Key149492132
Report Number1220246-2019-01181
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173656
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number3.0X130MM FIBULA NAIL, LEFT
Device Catalogue NumberAR-8973L-30-130
Device Lot Number10297815
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/08/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/27/2019 Patient Sequence Number: 1
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