MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72202901

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

Patient Problems Injury (2348); Osteolysis (2377)

Event Date 07/01/2012

Event Type  Injury  

Event Description

It was reported that, after an arthroscopic rotator cuff repair, the patient developed osteolysis around the footprint ultra suture anchor.It is unknown if the event required additional treatment.The patient's outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H11: correction on the facility information, e1.

Manufacturer Narrative

Evaluation is not possible, as the device will not be returned.The lot number has not been provided making an examination of the manufacturing records prohibitive.A review of the complaint records was performed for this device, which confirmed additional allegations have been reported within the scope of the reported study.The investigation was limited to the information provided.This investigation could not draw any conclusions about the reported event with the limited clinical details provided.If additional details become available in the future, the investigation will be reopened.The data presented in the aged article does not provide insight or relevance to current clinical outcomes for the product/device.Without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.

• Brand Name: FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10280690
• MDR Text Key: 199047499
• Report Number: 1219602-2020-01052
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010650528
• UDI-Public: 03596010650528
• Combination Product (y/n): N
• PMA/PMN Number: K093837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 72202901
• Device Catalogue Number: 72202901
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention