FDA Adverse Event Malfunction Summary report: N

CAPSULECLOSE SCORPION

MDR report key: 11872417 · Received May 24, 2021

Report

Report Number: 1220246-2021-03164
Event Type: Malfunction
Date Received: May 24, 2021
Date of Event: May 4, 2021
Report Date: August 2, 2021
Manufacturer: ARTHREX, INC.
Product Code: LXH
UDI-DI: 00888867212688
PMA / PMN Number: EXEMPT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MI, US
Reporter Occupation: 501

Narratives

Additional Manufacturer Narrative · 0

COMPLAINT CONFIRMED. ONE UNPACKAGED AR-16992, BATCH 10359098 CAPSULECLOSE SCORPION WAS RECEIVED FOR INVESTIGATION. VISUAL INSPECTION IDENTIFIED THAT THE 118-204 SHEAR PIN, 910-019 SUTURE CLIP, AND THE 910-021 SUTURE CLIP SPRING COMPONENTS HAD BROKEN OFF OF THE DISTAL TIP OF THE SCORPION. THE FRAGMENTS GENERATED DURING THIS EVENT WERE NOT RETURNED FOR ANALYSIS. FUNCTIONAL TESTING REVEALED THAT SQUEEZING THE FINGER ALLOWED THE TISSUE CLAMP ASSEMBLY TO ADVANCE AS INTENDED, ALTHOUGH USABILITY WAS IMPEDED BY THE LACK OF TIP COMPONENTS PRESENT. THE OBSERVED CONDITION IS MOST LIKELY THE RESULT OF BREAKAGE AT THE SHEAR PIN AS A RESULT OF DROPPING THE DEVICE OR SMASHING THE DEVICE INTO SOLID MATERIAL.

Additional Manufacturer Narrative · 1

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. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE TIP OF THE AR-16992 SCORPION BROKE OFF. THE SALES REP REPORTED THE CASE WAS COMPLETED WITHOUT INCIDENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
770172	CAPSULECLOSE SCORPION	PLATE, FIXATION, BONE	LXH	ARTHREX, INC.	CAPSULECLOSE SCORPION	10359098	00888867212688

Patients

Seq	Age	Sex	Outcome	Treatment
1