MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIRPTR 2.3 PK SUTURE ANCHOR W/ ULTRAB; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	72201541
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Investigation results need to be approved again.A supplemental mdr will be submitted once available.
Event or Problem Description
It was reported that during surgery, the bioraptor anchor came out after the knot was put.The procedure was completed without delay using a back-up device.No patient injury or other complications were reported.Results of investigation have concluded that anchor fractured which makes it a reportable event.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
H10 h3, h6 the reported 2.3 bioraptor pk suture anchor, used in treatment, was returned for evaluation.Visual assessment of the device showed the anchor is free from the inserter.Approximately 2.4mm of the proximal end of the anchor has been broken off and was not returned.The major diameter of the anchor was found to meet print specifications.An exact root cause cannot be determined with confidence.

• Brand Name: BIRPTR 2.3 PK SUTURE ANCHOR W/ ULTRAB
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9936506
• Report Number: 1219602-2020-00614
• Device Sequence Number: 2717727
• Product Code: MBI
• UDI-Device Identifier: 03596010595072
• UDI-Public: 03596010595072
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K071586
• 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): 04/21/2020

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: 05/15/2023
• Device Model Number: 72201541
• Device Catalogue Number: 72201541
• Device Lot Number: 50735704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2020
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1