MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SCREW BIOSURE REGENESORB 10MM X 30MM; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number 72204409

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

Foreign zip code: (b)(6).

Event Description

It was reported that during the surgery when the screw was being inserted into to bone tunnel it broke off.No patient injuries or significant delays reported.The back-up device was available to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10.H3, h6: one 10x30mm biosure regenesorb screw, used in treatment, has been returned for evaluation.Visual assessment of the screw confirmed the reported complaint.The screws proximal threads are deformed and are missing pieces.Dimensional assessment of the screws major diameter and wall thickness was performed and found to meet print specifications.An exact root cause cannot be determined with confidence without the pertinent clinical details; however, factors that could have contributed to the reported event include: not preparing the insertion site as required by the instructions for use.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 and complaint records was performed, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SCREW BIOSURE REGENESORB 10MM X 30MM
• Type of Device: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes boulevard; mansfield MA 02048
• MDR Report Key: 9520304
• MDR Text Key: 173801336
• Report Number: 1219602-2019-01635
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 00885554036855
• UDI-Public: 00885554036855
• Combination Product (y/n): N
• PMA/PMN Number: K142948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Model Number: 72204409
• Device Catalogue Number: 72204409
• Device Lot Number: 50694096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2020
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1