MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 48MM; SCREW, FIXATION, BONE

Model Number	02.211.048
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	12/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Additional pro-code: hrs.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 as no product was received.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 on (b)(6) 2019, the patient underwent scheduled removal hardware of a variable angle locking compression plate (va-lcp) olecranon plate, upon removing the proximal 2.7mm va screws, 2 of the 3 screws broke just below the head of the screw.Multiple attempts were made using the broken screw removal instruments to remove the screws from the synthes broken screw removal set, which were unsuccessful.Hardware was left in the extremity.The procedure was successfully completed with ten (10) minutes of surgical delay.Patient status was unknown.Concomitant device reported: unknown broken screw removal instruments (part # unknown, lot # unknown, quantity unknown), unknown screw (part # unknown, lot # unknown, quantity 1).This complaint involves three (3) devices.This report is 1 of 2 for (b)(4).

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 48MM
• 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: 9507684
• Report Number: 2939274-2019-62739
• Device Sequence Number: 16644639
• Product Code: HWC
• UDI-Device Identifier: 10886982053756
• UDI-Public: (01)10886982053756
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 02.211.048
• Device Catalogue Number: 02.211.048
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/20/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR