MAUDE Adverse Event Report: ARTHREX INC. MENISCAL ROOT KIT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Catalog Number	AR-4550
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It reported that during a meniscal repair procedure, the tip of the scorpion needle (lot: 10034428) broke off into the patient's knee joint.The case was completed with the same needle.It wasn't noticed that the tip had broken off until a post-op x-ray was taken and the tip was seen in joint space.The surgeon is comfortable leaving the tip in the knee.Reporter had no additional information.
Event or Problem Description
It reported that during a meniscal repair procedure, the tip of the scorpion needle (lot: 10034428) broke off into the patient's knee joint.The case was completed with the same needle.It wasn't noticed that the tip had broken off until a post-op x-ray was taken and the tip was seen in joint space.The surgeon is comfortable leaving the tip in the knee.Reporter had no additional information.
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.The failure mode could not be determined, but the broken needle point condition can be caused by consistently passing the needle through challenging tissue (thick or calcified) or hitting bone.The mating part (instrument) was not returned or identified.Confirmed the needle strip thickness and width dimensions to be within specification.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.

• Brand Name: MENISCAL ROOT KIT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7577713
• Report Number: 1220246-2018-00212
• Device Sequence Number: 19285953
• Product Code: GAT
• UDI-Device Identifier: 00888867217379
• UDI-Public: 00888867217379
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2018

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: 06/01/2021
• Device Catalogue Number: AR-4550
• Device Lot Number: 10037764A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/16/2018
• Supplement Date Received by Manufacturer: 05/16/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 07/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other