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

Catalog Number	72201541
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during an instability procedure the bioraptor 2.3 pk suture anchor came out.Back up device was use in additional bone hole to completed the procedure without delay.No patient injury 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
One bioraptor 2.3mm pk suture anchor device used for treatment, was not returned for evaluation.Due to product unavailability, the complaint could not be ultimately confirmed.Definitive conclusions, accurate investigation and evaluation were limited without evaluation of physical product.If objective evidence, relevant information, packaging or product becomes available to assist with evaluation, the complaint will be revisited.Factors that may affect device performance include: device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity that are unrelated to manufacture include: prep and proceeding per instructions for use recommendations is essential for successful use of this product.Following these 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.A two-finger ao technique should be used to insert the anchor.Breakage of the suture anchor can occur if insertion sites are not prepared with appropriate instrumentation prior to implantation.¿ product met specifications upon release to distribution.

• 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: 9347613
• Report Number: 1219602-2019-01457
• Device Sequence Number: 11108844
• 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): 12/10/2019

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: 05/23/2023
• Device Catalogue Number: 72201541
• Device Lot Number: 50737687
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2019
• Supplement Date Received by Manufacturer: 12/06/2019
• Initial Report FDA Received Date: 11/20/2019
• Supplement Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1