MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIRAPTR 2.9 AB SUTR ANCR TWO 38 U/B; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72201702
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that, during an elbow procedure, the bioraptor anchor broke.All fragments were retrieved from within the patient.An additional bone hole had to be drilled in order to use the backup device which was available to complete the procedure.No significant delay or patient injury was reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H3, h6: one 72201702 bioraptor suture anchor device intended for treatment, was not returned for evaluation.Factors that may affect device performance include: device ability, surgical ability, implant location, tissue condition and surgical site preparation according to instructions for use, it confirms instructions, precautionary statements and recommendations for proper use of product.Per instruction for use: ¿read these instructions completely prior to use.It is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.¿ instruction for use indicates use of this device for hip and shoulder applications.The procedure was reported to be an elbow procedure.This application is not captured as an indication for use.Complaint history review indicated a similar (related) allegation for the lot number reported.Dhr/batch/lot review did not indicate a condition or product/procedure failure that supported the allegation.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.No further investigation is warranted at this time.

• Brand Name: BIRAPTR 2.9 AB SUTR ANCR TWO 38 U/B
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9372046
• Report Number: 1219602-2019-01482
• Device Sequence Number: 14260291
• Product Code: MAI
• UDI-Device Identifier: 03596010607553
• UDI-Public: 03596010607553
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2020

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: 11/08/2021
• Device Model Number: 72201702
• Device Catalogue Number: 72201702
• Device Lot Number: 50769475
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 01/27/2020
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR