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

Model Number	72201543
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported about a 2.3mm peek bioraptor suture anchor (ultrabraid #2 suture) that, during an unknown procedure, the anchor got pulled out and could not be fixed in the target tissue.The procedure was successfully completed without delay using a back-up device into an additional bone hole.No patient injuries or other complications were reported.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: one 72201543 bioraptor 2.3mm pk suture anchor device in treatment, was returned for evaluation.Instructions for use contain recommendations and precautionary statements for proper use of product.The inserter and two partial cobraid suture were the only items returned.The inserter displayed no obvious sign of damage.There were markings up and down the inserter shaft as with strong enzymatic cleaning agents affecting the finish.Prep and proceeding per instructions for use recommendations is essential for successful use of this product.Following the recommendations is essential to a successful implant.Per instructions for use: use of approved smith and nephew instrumentation is strongly recommended to prepare the insertion site and maintain axial alignment between insertion site and the bioraptor suture anchor.When using bioraptor 2.3 mm suture anchors, use a smith and nephew 2.3 mm drill guide, 2.3 mm obturator, and a drill bit specific to the suture anchors to prepare the insertion site (each sold separately).It is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Use of excessive force during insertion can cause failure of the suture anchor or insertion device.Breakage of the suture anchor can occur if insertion sites are not prepared with appropriate instrumentation prior to implantation.Complaint history review indicated no similar allegations for the lot number reported.Batch review indicated no condition, product or procedure failure that supported the allegation.No root cause related to the manufacturing of this device was confirmed.
Additional Manufacturer Narrative
The reported 2.3 curved bioraptor pk suture anchor assembly, used in treatment, has not been returned for evaluation.Without the reported product a visual evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, anchor would not secure at insertion site.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: pathological conditions of bone, such as cystic changes or severe osteopenia, which would compromise secure anchor fixation the instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: BIRPTR 2.3 PK SUT ANCHR W/ ULTRAB WTE
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9805745
• Report Number: 1219602-2020-00482
• Device Sequence Number: 778125
• Product Code: MBI
• UDI-Device Identifier: 03596010595096
• UDI-Public: 03596010595096
• 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,Followup
• Report Date (Section B): 06/26/2020

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: 09/20/2023
• Device Model Number: 72201543
• Device Catalogue Number: 72201543
• Device Lot Number: 50760144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Initial Date Received by Manufacturer: 02/01/2020
• Supplement Date Received by Manufacturer: 03/25/2020; 06/25/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 03/27/2020; 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1