MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIORAPTOR,CRV 2.3; BIORAPTOR CURVED 2.3 PK SUTURE ANCHOR

Catalog Number 72203281

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2015

Event Type  malfunction  

Manufacturer Narrative

Device is not being returned for evaluation.A review of the quality records associated with this manufactured lot confirmed that two additional complaints have been filed from this facility for the identical failure mode.A review of the device history records associated with this product lot confirmed no abnormalities were reported during manufacture.Further investigation is not warranted at this time.(b)(4).

Event Description

It was reported that during a shoulder arthroscopy procedure using bioraptor,crv 2.3 pk sa ub cobrd blue the anchor pulled out.Another anchor was used as a backup device placed in the same site.It is unknown if there was a procedural delay.There are no reports of patient injuries or complications.

• Brand Name: BIORAPTOR,CRV 2.3
• Type of Device: BIORAPTOR CURVED 2.3 PK SUTURE ANCHOR
• 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: james gonzales ; 150 minuteman road; andover, MA 01810 ; 5123585706
• MDR Report Key: 4934727
• MDR Text Key: 22782505
• Report Number: 1219602-2015-00423
• Device Sequence Number: 1
• Product Code: MBI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2019
• Device Catalogue Number: 72203281
• Device Lot Number: 50522263
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2015
• Date Device Manufactured: 10/03/2014
• 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