MAUDE Adverse Event Report: WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM; SCREW, FIXATION, BONE

Model Number	202.878
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: (b)(4).Lot unknown.Device malfunctioned intra-operatively and was not implanted / explanted.Complainant part 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 during an open reduction internal fixation (orif) of the ulna procedure on (b)(6) 2017, the head of a 2.7mm 18mm cortex screw broke off into the patient as the surgeon was screwing it into a 2.7mm locking compression plate (lcp) plate.Fragments were generated in the patient and part of the screws threading was reported to be left in the patient¿s arm.All other fragments were reported as easily removed.During the time of the break, two (2) other 2.7mm 18mm cortex screws and the 2.7mm lcp plate were implanted in the patient.The plate and 2 screws remained in the patient and the surgery was completed using another 2.7mm 18mm cortex screw.The patient was reported to be in good condition following the procedure.There was a reported 10-minute surgical delay due to the break.Concomitant device reported: 2.7mm lcp plate 10 holes / 94mm (247.374, lot number unknown, quantity 1), screwdriver (part number unknown, lot number unknown, quantity 1).(b)(4).

• Brand Name: 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM
• 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: 7146262
• Report Number: 2939274-2017-50425
• Device Sequence Number: 10994843
• Product Code: HWC
• UDI-Device Identifier: 10886982145086
• UDI-Public: (01)10886982145086(10)LOTUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K113364
• 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): 11/28/2017

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: 202.878
• Device Catalogue Number: 202.878
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/28/2017
• Initial Report FDA Received Date: 12/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 66