MAUDE Adverse Event Report: ABBOTT MEDICAL SWIFT-LOCK ANCHOR; SWIFT LOCK ANCHOR

Model Number 1192

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 11/13/2020

Event Type  Injury  

Manufacturer Narrative

Date of the event is estimated.During processing of this complaint, attempts were made to obtain complete patient information.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 1627487-2020-48169.It was reported the patient was experiencing pain at the anchor site.Surgical intervention took place on (b)(6) 2020 in which the anchors were sutured down deeper to address the issue.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.  based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Additional information indicates the pain has resolved.

• Brand Name: SWIFT-LOCK ANCHOR
• Type of Device: SWIFT LOCK ANCHOR
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10899088
• MDR Text Key: 218185066
• Report Number: 1627487-2020-48170
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05415067024084
• UDI-Public: 05415067024084
• Combination Product (y/n): N
• PMA/PMN Number: K092371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2021
• Device Model Number: 1192
• Device Catalogue Number: 1192
• Device Lot Number: 7146268
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 12/01/2020
• Supplement Dates FDA Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL # 1192 - ANCHOR; MODEL # 1192 - ANCHOR
• Patient Outcome(s): Other
• Patient Age: 43 YR