MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIORAPTOR CRV 2.3 PK SA UB COBRD BLACK; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72203280
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	02/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a drying vs procedure four bioraptor anchors were used but the fifth had an issue.The anchor exceeded the area applied, the diameter of the anchor has a structure that did not allow to enter to the tissue, for this reason the anchor could not be secured.An additional bone hole was required, there was loss of tissue and a void was left in the patient.A backup device was available to complete the procedure with no significant delay or patient injuries.
Additional Manufacturer Narrative
One 2.3 curved bioraptor pk suture anchor assembly was returned for evaluation.Visual assessment of the device showed the distal end of the inserter is bent.The anchor is free from the inserter.No suture remains on the anchor or inserter or was returned for evaluation.Dimensional assessment of the anchor and inserter was performed and found to meet print specifications.This investigation could not identify any evidence of product contribution to the reported complaint.

• Brand Name: BIORAPTOR CRV 2.3 PK SA UB COBRD BLACK
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8446432
• Report Number: 1219602-2019-00340
• Device Sequence Number: 2978287
• Product Code: MBI
• UDI-Device Identifier: 03596010656452
• UDI-Public: 03596010656452
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K102660
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2023
• Device Catalogue Number: 72203280
• Device Lot Number: 50766561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1