MAUDE Adverse Event Report: SONOMA ORTHOPEDIC PRODUCTS, INC. SONOMA CRX; CLAVICLE NAIL

Catalog Number	CRX-WG2-40110-S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following methodologies were used to investigate this event: interview with distributor representative; review of implantation floroscope images; review of post failure x-ray images; review of manufacturing and quality records for lot; review of surgical technique and instructions for use.Nail was improperly placed by surgeon during implantation.Cross locking lateral screw was not in contact with the posterior surface of the clavicle.Nail was not placed at the required depth of >50mm past the fracture which placed excessive loading on the wavy body section of the implant.Surgeon has elected to leave the implant in place as he has observed callus formation and expects the patient to recover.Review of manufacturing and quality records do not reveal any non-conformances or problems in the manufacture of the device lot.Report is being submitted as it is the opinion of the sonoma orthopedic products, inc that there is a reasonable likelyhood that surgical intervention will be required in this case.Device was evaluated by observation of available x-ray images.There was no in situ testing performed on the devicedevice not returned for evaluation.
Event or Problem Description
Patient implanted with sonoma crx clavical nail on (b)(6) 2016.Patent claims to have awoke on (b)(6) 2015 with shoulder pain.X-rays reveal that the implant was broken.

• Brand Name: SONOMA CRX
• Common Device Name: CLAVICLE NAIL
• Manufacturer (Section D): SONOMA ORTHOPEDIC PRODUCTS, INC.; 1388 busch parkway; buffalo grove IL 60089
• MDR Report Key: 5542613
• Report Number: 3007038372-2016-00001
• Device Sequence Number: 16348941
• Product Code: HSB
• UDI-Device Identifier: 00816988010999
• UDI-Public: (01)00816988010999(17)170801(10)CU26081501
• Combination Product (Y/N): N
• PMA/510(K) Number: K092110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/01/2016

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: Physician
• Device Expiration Date: 08/01/2017
• Device Catalogue Number: CRX-WG2-40110-S
• Device Lot Number: CU260815-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2016
• Initial Report FDA Received Date: 04/01/2016
• 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