MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE PK 7 X 25MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202263
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during a mpfl procedure, when the surgeon inserted the screw to the bone tunnel it wouldn't engage.He backed the screw out to find the tip had caved in.Backup device was available to complete the procedure.No delay and no patient injuries were reported.
Additional Manufacturer Narrative
One 72202663 biosure peek 7x25mm screw used for treatment, was returned for evaluation.The complaint stated: inserted the screw to the bone tunnel it wouldn't engage.He backed the screw out to find the tip had caved in.The product was disfigured.The product has been shortened by nearly 2mm which was found pushed up inside the distal inner diameter.There was a burnished and flared appearance which was caused from contact with an instrument and/or tissue during continued rotation and force combination.The pushed material and flaring was caused by force of material(s) into a lesser cannulation space than was able to accommodate.Per instruction for use and technique guide: drill the appropriate diameter tunnel.Measure the diameter of the combined tendon end of the graft using a slotted sizing block which will provide the diameter required for femoral drilling.Following recommended prep is critical for ease of insertion and successful anchoring.Per instruction 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.No root cause associated with the manufacture of this device was confirmed.Product met specifications upon release to distribution.

• Brand Name: BIOSURE PK 7 X 25MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8909956
• Report Number: 1219602-2019-00984
• Device Sequence Number: 19317197
• Product Code: MBI
• UDI-Device Identifier: 03596010621610
• UDI-Public: 03596010621610
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: AS
• 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): 08/29/2019

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: 09/18/2023
• Device Catalogue Number: 72202263
• Device Lot Number: 50759546
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 08/28/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 08/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1