MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE PK 9 X 30MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202273
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Foreign zip code: (b)(4).
Event or Problem Description
It was reported that during an unknown procedure the item broke.The procedure was completed with a backup device with no significant delay or patient injury reported.
Additional Manufacturer Narrative
One biosure peek 9x30mm screw, 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 certainly be revisited.Factors that may affect device performance include: device ability, surgical ability, implant location and tissue condition.Review of instruction for use documentation confirms instructions, precautionary statements and recommendations for proper use of product.Influences that could compromise product performance or integrity that are unrelated to manufacture include: 1.Use of damaged or other than recommended prep instrument size and/or types.2.Not accounting for taper or larger head to body design.3.Entanglement with guide wire or other instrument causing tearing and fractures.4.Unexpected bone density/condition.5.Use of excess torque or force.Prep per the instructions for use recommendation is critical for ease of insertion and successful anchoring.Per instructions for use: ¿it is the surgeon¿s responsibility to be familiar with the appropriate surgical techniques prior to use of this device.Read these instructions completely prior to use.Breakage of the screw or loss of fixation may occur if the insertion site is not prepared with the recommended smith and nephew drill and/or tap prior to implantation.Excessive force should not be placed on the delivery instrument.¿ product met specifications upon release to distribution.Complaint history review found no other report for this lot.

• Brand Name: BIOSURE PK 9 X 30MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8639856
• Report Number: 1219602-2019-00595
• Device Sequence Number: 1831947
• Product Code: MBI
• UDI-Device Identifier: 03596010622082
• UDI-Public: 03596010622082
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K083635
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/04/2019

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: 01/24/2023
• Device Catalogue Number: 72202273
• Device Lot Number: 50710052
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/14/2019
• Supplement Date Received by Manufacturer: 07/03/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 07/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1