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	Perforation (2001)
Date of Event	05/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report source: (b)(6).
Event or Problem Description
It was reported that during a revision acl surgery the outer layer of the screw crumbled as it was halfway in.All the broken pieces were removed successfully using a grasper and no product was used after.No significant delay or patient injuries were reported.
Additional Manufacturer Narrative
One 72204404 biosure regenesorb 9mm x 25mm screw returned.The complaint stated: ¿the outer layer of the screw crumbled as it was halfway in.¿ this implant was received in extremely poor condition.Dimensional inspection verifies that this was a 9x25mm product.The thread conditions range from rolled over to missing material.The phillips head shows light stripping had begun.The outer diameter edges are distorted; rolled, burnished and peeling.Symptoms indicate threads met with resistance, force and over-torque.No root cause related to the manufacturing of this device was confirmed.

• 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: 8679766
• Report Number: 1219602-2019-00661
• Device Sequence Number: 1729415
• Product Code: MAI
• UDI-Device Identifier: 00885554036800
• UDI-Public: 00885554036800
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K142948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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: 01/03/2021
• Device Catalogue Number: 72204404
• Device Lot Number: 50705635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Received by Manufacturer: 05/24/2019
• Supplement Date Received by Manufacturer: 06/14/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1