MAUDE Adverse Event Report: SMITH & NEPHEW, INC. OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	72203290
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/29/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an open reduction and internal fixation of left fifth metatarsal fracture, the anchor was fractured when screw in.The procedure was successfully completed with a backup device and no significant delay or further complications reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
One curved osteoraptor device used in treatment, was returned for evaluation.Instruction for use contains precautionary statements and recommendations for proper use of product.Per instruction for use recommendation is critical for ease of insertion and successful anchoring.The product is intended for hip and shoulder applications.The listed procedure was a ¿metatarsal fracture¿ which may have contributed to the failure.The inserter was returned bent at the distal end.The anchor was fractured at the proximal end where it was completely split open.This typically occurs with loss of axial alignment, use for leverage and excess torque applied.One strand of cobraid was loosely attached to the anchor but not the inserter.Per instruction for use: 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.Implantation of the osteoraptor curved 2.3 suture anchor requires preparation of the insertion site.Pre-drilling with the appropriate smith & nephew flexible drill bit while using the smith & nephew curved guides is the required method of site preparation.Only use the appropriate flexible drill bits, flexible obturators, and curved guides intended for use with the osteoraptor curved 2.3 suture anchors.Use of other instruments may injure the patient, damage the instruments, or compromise the fixation.No indication suggests product did not meet specifications upon release for distribution.Product met specifications upon release to distribution.

• Brand Name: OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10292265
• Report Number: 1219602-2020-01076
• Device Sequence Number: 923226
• Product Code: MAI
• UDI-Device Identifier: 00885554022254
• UDI-Public: 00885554022254
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/02/2024
• Device Model Number: 72203290
• Device Catalogue Number: 72203290
• Device Lot Number: 2027400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2020
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 07/29/2020
• Initial Report FDA Received Date: 07/17/2020
• Supplement Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Weight: 70