MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIORAPTOR; BIRPTR 2.3 PK SUTURE ANCHOR W/ UB

Model Number 72201541

Device Problems Loose or Intermittent Connection (1371); Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

Patient suffered crepitus(definition: grating, crackling or popping sounds and sensations experienced under the skin and joints or a crackling sensation) 3 months post operatively and on re-operation, it became obvious that the anchor had backed out.Joint surface appears to have degenerated as a result of the proud anchor.

Manufacturer Narrative

(b)(4).

• Brand Name: BIORAPTOR
• Type of Device: BIRPTR 2.3 PK SUTURE ANCHOR W/ UB
• 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: donna lanteigne ; 150 minuteman road; andover, MA 01810 ; 9787491576
• MDR Report Key: 4156725
• MDR Text Key: 4782103
• Report Number: 1219602-2014-00290
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K071586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Model Number: 72201541
• Device Catalogue Number: 72201541
• Device Lot Number: 50445528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/19/2014
• Date Device Manufactured: 01/14/2013
• 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): Required Intervention
• Patient Age: 23 YR