MAUDE Adverse Event Report: MEDLINE RENEWAL ARTHREX; SCORPION¿ NEEDLE, FOR USE WITH SCORPION¿ SUTURE PASSER, (BLUE)

Catalog Number AR13990NR

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the tip of the reprocessed arthrex scorpion¿ suture passer (blue) broke off into the patient during an unidentified left shoulder surgery.Reportedly, the incident happened while trying to pass a suture through the shoulder.It was added that the surgeon could not find the tip and assumed it was left inside the patient.The patient was notified post-op and reportedly refused an x-ray to determine if the tip was retained in the shoulder.Due to the reported event, 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 indicated that all processes were conducted as required at the time the lot was processed.A root cause for the reported issue could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that the tip of the reprocessed arthrex scorpion¿ needle passer broke off into the patient and could not be found.

• Brand Name: ARTHREX
• Type of Device: SCORPION¿ NEEDLE, FOR USE WITH SCORPION¿ SUTURE PASSER, (BLUE)
• 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: 8754915
• MDR Text Key: 150121196
• Report Number: 3032391-2019-00014
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/02/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Catalogue Number: AR13990NR
• Device Lot Number: 414465
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2019
• Initial Date FDA Received: 07/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 60 YR