MAUDE Adverse Event Report: SMITH & NEPHEW, INC. BIOSURE PK, 8 X 30MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Catalog Number	72202269
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, while implanting the device, the screw broke off.All the pieces were removed.A backup device was available to complete the procedure with no significant delay and no patient injuries.
Additional Manufacturer Narrative
One (b)(4) biosure peek 8x30mm screw returned.Dimensional inspection confirmed this was an 8x30mm product.The complaint stated: ¿the screw broke off.¿ there is obvious damage attained.The major diameter of the distal threads are disfigured and the body has been fractured.The appearance is consistent with off axis rolling with attempted insertion.There is also vertical damage that is symptomatic of entanglement with another device or guidewire.A recommendation is critical for ease of insertion and successful anchoring.¿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 related to the manufacturing of this device was confirmed.

• Brand Name: BIOSURE PK, 8 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: 8107992
• Report Number: 1219602-2018-01630
• Device Sequence Number: 14044483
• Product Code: MBI
• UDI-Device Identifier: 03596010622051
• UDI-Public: 03596010622051
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2019

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: 72202269
• Device Lot Number: 50710051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2018
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 01/23/2019
• Initial Report FDA Received Date: 11/27/2018
• Supplement Report FDA Received Date: 01/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 49