MAUDE Adverse Event Report: FLOWER ORTHOPEDICS CANNULATED SCREW, PARTIALLY THREADED D: 2.4MM X L:10MM; CANNULATED BONE SCREW

Catalog Number	CSP 110
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Recall was not initiated because none of the affected lots are in the field.All the ones in inventory will be scrapped according to internal nonconforming product procedure.Patient monitoring is not necessary because none of the affected lots were ever implanted.
Event or Problem Description
Csp 110, lot 2013004855, contained a 15mm screw instead of a 10mm screw.The sales rep was able to detect the product problem and the screw was not used in surgery.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED D: 2.4MM X L:10MM
• Common Device Name: CANNULATED BONE SCREW
• Manufacturer (Section D): FLOWER ORTHOPEDICS; 100 witmer rd; suite 280; horsham PA 19044
• MDR Report Key: 6226330
• Report Number: 3009996260-2016-00007
• Device Sequence Number: 10783687
• Product Code: HWC
• UDI-Device Identifier: 00840118105330
• UDI-Public: 840118105330
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K132248
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Other,Notification
• Type of Report: Initial
• Report Date (Section B): 12/29/2016

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: Medical Equipment Company Technician/Representative
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: CSP 110
• Device Lot Number: 2013004855
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2016
• Initial Report FDA Received Date: 01/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other