MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 40MM; SCREW, FIXATION, BONE

Model Number	02.211.040
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	11/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient¿s identifier and weight are unknown.Additional device product code: hrs.Due to the intra-operative events, the device was not successfully implanted.An alternate device was used to complete procedural step.As such, implant/explant dates are not applicable.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 during an initial surgery on (b)(6) 2017, a 2.7mm variable angle locking screw would not lock into the locking hole of a 2.7mm/3.5mm variable locking compression (lcp) olecranon plate.The surgeon initially used a locking tower as opposed to a variable angle cone to tighten the screw which may have led to the screw not properly locking.After failed attempts of securing the screw it was removed and discarded.A new similar screw was used to replace the initial screw placing it through a different hole on the plate.There was approximately one (1) minute delay to replace the screw.The surgery was completed successfully and the patient outcome was noted as stable.Concomitant part: 2.7mm/3.5mm variable lcp olecranon plate 4h/rt116mm (part number unknown, lot number unknown, quantity 1).This report is for one (1) 2.7mm va locking screw this is report 1 of 1 for complaint (b)(4).

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 40MM
• 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: 7075885
• Report Number: 1719045-2017-50011
• Device Sequence Number: 939628
• Product Code: HWC
• UDI-Device Identifier: 10886982053718
• UDI-Public: (01)10886982053718(10)LOTNUMBERUNKNOWN
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K100776
• 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): 11/03/2017

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: 02.211.040
• Device Catalogue Number: 02.211.040
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR