MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 8MM X 25MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number 72204399

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 01/29/2019

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2019, an acl reconstruction was performed; good procedures and the knee was stable.After 6 months during the rehab period, the patient started to have pain on the insertion of the tibial screw.After doing sports, a bubble with liquid was also formed; therefore, a surgery was performed in order to extract the particles out of the tunnel.The patient outcome is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

One 8x25mm biosure regenesorb screw, used in treatment, has been returned for evaluation.The screw was returned in seven small fragments of varying sizes, the fragments are soiled with human matter.Due to the size and condition of the fragments further evaluation is prohibitive.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: mild inflammatory or allergic reaction.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing, risk management documents and complaint records was performed, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.Further investigation is not warranted at this time.In conclusion: based on the limited information provided, the definitive root cause of the revision could not be determined.However, the insertion technique, onset and timing of weight-bearing activities, incisional weakness, nsaids, and/or an inflammatory/allergic/foreign body response could have been possible contributing factors.Also the age of the repair is still only 12 months out and it can take 24 months for the screw to be replaced by bone though bone ingrowth would have continued already within the past 12 months.The patient impact beyond the reported symptoms and explantation of the remnants could not be determined, as the patient outcome was reportedly ¿unknown¿.No further medical assessment can be rendered at this time.

• Brand Name: SCREW BIOSURE REGENESORB 8MM X 25MM
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9529808
• MDR Text Key: 174180780
• Report Number: 1219602-2019-01662
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00885554036756
• UDI-Public: 00885554036756
• Combination Product (y/n): N
• PMA/PMN Number: K142948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2021
• Device Model Number: 72204399
• Device Catalogue Number: 72204399
• Device Lot Number: 50746500
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1