MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 9MM X 25MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	72204404
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after the insertion of the interference screw, the surgeon explored arthroscopically the tunnel, during this, he found out two small pieces which were actually broken parts of the screw.The surgeon removed them and let the screw in place.No delay or patient injuries were reported.
Additional Manufacturer Narrative
One 9 x 25mm biosure regenesorb screw was reported on.It was used for treatment but was not returned for evaluation.Due to unavailability, the allegation could not be fully confirmed.Definitive conclusions, investigation and evaluation were limited without physical evaluation.If objective evidence becomes available to assist with evaluation, the complaint will be revisited.Factors that may affect device performance include: device storage, device ability, surgical ability, procedure location and tissue condition.Influences that could compromise product performance or integrity include: adherence to the instructions for use recommendations.Use of other than recommended prep instrument size or types.Getting entangled with other instruments or devices.Stripping or over torque.Damaged prep instruments.Unexpected bone density/condition.Review of instruction for use documentation confirms instructions, precautionary statements and recommendations for proper use of product.Prep per the ifu recommendation is critical for ease of insertion and successful anchoring.Per instructions for use: ¿use of a driver other than the appropriate biosure driver may result in breakage of the screw.Breakage of the screw or loss of fixation may occur if the insertion site is not prepared properly.Inspect to confirm that the interference screw is fully seated onto the driver prior to insertion.If the interference screw is not properly seated on the driver, damage to or breakage of the screw may result.Failure to fully seat the screw may result in breakage of the screw.The biosure tap is recommended for use with bone tendon bone grafts prior to inserting the interference screw.Final product met specifications upon release to distribution.
Additional Manufacturer Narrative
One 72204404 biosure regenesorb 9x25mm screw used for treatment, was partially returned for evaluation.The return consisted of two small segments of thread.They were indicative of force and torque factors.Prep per the ifu recommendation is critical for ease of insertion and successful anchoring.As this is a tapered product, the tunnel size needs to accommodate the largest diameter of the implant.Shattering and multiple fracture symptoms are often aligned with an inferior tunnel size.Instruction for use (ifu) confirms instructions, precautionary statements and recommendations for proper use of product.Per ifu: ¿use of a driver other than the appropriate biosure driver may result in breakage of the screw.Breakage of the screw or loss of fixation may occur if the insertion site is not prepared properly.Inspect to confirm that the interference screw is fully seated onto the driver prior to insertion.If the interference screw is not properly seated on the driver, damage to or breakage of the screw may result.Failure to fully seat the screw may result in breakage of the screw.The biosure tap is recommended for use with bone-tendon-bone grafts prior to inserting the interference screw.Use of a tap is recommended.In cases where hard bone is encountered, it is recommended that a tap 1mm larger than the screw be used.Complaint search revealed no other related complaints for the history of the manufacturing lot.No root cause related to the manufacture of the device was confirmed.Product met specifications upon release to distribution.

• Brand Name: SCREW BIOSURE REGENESORB 9MM X 25MM
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 8816339
• Report Number: 1219602-2019-00859
• Device Sequence Number: 321008
• Product Code: MAI
• UDI-Device Identifier: 00885554036800
• UDI-Public: 00885554036800
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K142948
• 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): 11/11/2019

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: 10/31/2021
• Device Catalogue Number: 72204404
• Device Lot Number: 50767596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 08/30/2019; 11/08/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 09/02/2019; 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1