MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIORAPTOR, KNOTLESS SUTURE ANCHOR; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Device Problem Noise, Audible (3273)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Device used in original procedure was given as bioraptor knotless.Part number and lot number are not available at this time.Requests for additional informations have been made.Date of implantation and date of product problem occurence have not been provided at this time.Requests for additional informations have been made.

Event Description

It was reported that a patient had a hip procedure completed with a knotless bioraptor anchor.One year after the procedure, the patient is in pain and hears clicking when walking up stairs.No information about the initial procedure has been made available at this time.There have been no indications that a revision surgery will be done at this time.

Manufacturer Narrative

Corrected to include adverse event.Corrected to include the re-evaluation rationale for this event being an adverse event.Brand name: corrected brand name to identify the device family associated with this event.Corrected to indicate that this event is a serious injury.Even though intervention has not yet been required, it is anticipated that it will be required to resolve the current issue.(b)(4).

Event Description

The originally filed description of this event is accurate.Additional information is being provided.This event was originally filed as a product problem because there has been no intervention to date.Further evaluation concluded that this event should probably be reported as an adverse event as well because there is a strong likelihood that some form of intervention will be required even though it has not yet taken place.

Manufacturer Narrative

Examination was not possible, as the device was not returned.The investigation was limited to the information provided.The investigation could not draw any conclusions about the reported event with the clinical details provided.A review of the device history record was not possible due to a lot number not being provided.No further investigation is warranted at this time.(b)(4).

• Brand Name: BIORAPTOR, KNOTLESS SUTURE ANCHOR
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• Manufacturer Contact: jim gonzales ; 7000 w william cannon dr.; austin, TX 78735
• MDR Report Key: 6599729
• MDR Text Key: 76392408
• Report Number: 1219602-2017-00560
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K093428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2017
• 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?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other