MAUDE Adverse Event Report: MEDLINE RENEWAL ARTHREX; SUTURELASSO¿ SD, 90 DEGREES UP (BLACK) 1.8MM

Catalog Number AR406890RH

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that during an unknown procedure, the tip of the reprocessed arthrex suturelasso sd, 90 degrees up (black) 1.8mm, broke off into patient.The tip of the device was reportedly retrieved from the surgical site through an unknown method.There was no report of a serious injury, an adverse patient consequence or prolonged anesthesia related to the incident.Due to the reported device failure and the required intervention to retrieve the device tip that broke off into patient, this medwatch is being filed.The sample is not available to be returned for evaluation.A review of the device history record for the reported lot number was performed and this review indicated that all processes were conducted as required at the time the lot was processed.A definitive root cause for the reported issue could not be determined at this time.No additional information is available.If additional relevant information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the tip of the reprocessed arthrex suturelasso sd broke off into patient.

• Brand Name: ARTHREX
• Type of Device: SUTURELASSO¿ SD, 90 DEGREES UP (BLACK) 1.8MM
• Manufacturer (Section D): MEDLINE RENEWAL; 1500 ne hemlock ave; redmond OR 97756
• Manufacturer Contact: stephen wilson ; 1500 ne hemlock ave; redmond, OR 97756
• MDR Report Key: 9376344
• MDR Text Key: 190132842
• Report Number: 3032391-2019-00029
• Device Sequence Number: 1
• Product Code: HWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: AR406890RH
• Device Lot Number: 421796
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention