MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM; SCREW,FIXATION,BONE

Model Number	201.774
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient¿s identifier is unknown.Additional device product code: hrs.Not implanted or explanted, partial device remained in patient.Complainant device is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that a 2.4 mm locking compression plate (lcp) and four (4) 2.4 mm cortex screws were used for provisional fixation to hold reduction of fragments during an orif(open reduction internal fixation) of a humerus.Reduction was achieved and surgeon began to remove the 2.4 mm lcp plate and 2.4 mm cortex screws when one of the head of the 2.4 mm cortex screw broke and the shaft of the screw was retained in the patient.The surgeon did not attempt removal of the screw shaft.The three (3) remaining 2.4 mm cortex screws were easily removed.A 3.5 mm lcp periarticular proximal humerus plate was applied along with a combination of 3.5 mm locking screws and 3.5 mm cortical screws for successful completion of the procedure.There was no surgical delay, routine intraoperative x-rays were taken.The patient was reported to be stable.The broken screw head was discarded by the hospital along with the 2.4 mm lcp plate and the remaining (3) 2.4 mm cortex screws.Concomitant devices reported: 2.4 mm lcp plate (part # unknown, lot # unknown, quantity of 1), screwdriver (part # unknown, lot # unknown, quantity of 1).This report is for one (1) 2.4 mm cortex screw slf-tpng with t8 stardrive recess 24 mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 24MM
• Common Device Name: SCREW,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 7106044
• Report Number: 2939274-2017-50209
• Device Sequence Number: 19141270
• Product Code: HWC
• UDI-Device Identifier: 10886982142801
• UDI-Public: (01)10886982142801(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/13/2017

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 Model Number: 201.774
• Device Catalogue Number: 201.774
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2017
• Initial Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 98