MAUDE Adverse Event Report: ARTHREX, INC. NEEDLE, MINI SCORPION DX; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	NEEDLE, MINI SCORPION DX
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/03/2018
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 scorpion needle ar-8999n broke off intraoperatively during the application in the osg of the patient.The tip could no longer be seen / found, thus remaining in the patient.Osg arthroscopic inner and outer band repair was performed.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.Update 07sep18: anterior ankle arthroscopy with medial and lateral ligament repair: when piercing the mini-scorpion needle in the deep leaf of the medial deltoid ligament, the tip of the needle is broken off.When withdrawing the mini-scorpion, this was noticed and carefully tried to find and grasp the small needle tip.By circulating the arthroscopic irrigation fluid, however, the needle tip was irrigated into the posterior compartment behind the ankle joint, which could be demonstrated intraoperatively with a mini-bv.After several attempts to move the needle tip back into the anterior compartment, it remained stable posterior, probably trapped in the posterior joint capsule.After completion of the medial and lateral ligamentous repair, a new fluoroscopy with stable persistence of the needle tip in the posterior compartment, clearly behind the joint gap, even with full dorsal extension and plantarflexion.If the needle tip should interfere as a foreign body, a posterior ankle arthroscopy in prone position would have to be discussed with the patient in order to remove the needle tip.
Additional Manufacturer Narrative
Complaint confirmed.The returned ar-8999 met all as-received specifications.Visual evaluation revealed that the distal tip of one of the scorpion needles had broken off proximal to the suture notch prior to receipt for investigation.The second of the returned devices displayed no abnormalities.The typical cause for this type of event would be the use of excessive force to pass the needle through thick or hard tissue, or hitting bone with the needle.

• Brand Name: NEEDLE, MINI SCORPION DX
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7893444
• Report Number: 1220246-2018-00657
• Device Sequence Number: 11239919
• Product Code: LXH
• UDI-Device Identifier: 00888867056855
• UDI-Public: 00888867056855
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2018

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 Date: 06/30/2022
• Device Model Number: NEEDLE, MINI SCORPION DX
• Device Catalogue Number: AR-8999N
• Device Lot Number: 10149294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Received by Manufacturer: 09/05/2018
• Supplement Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 11/29/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other