MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 10MM; SCREW,FIXATION,BONE

Model Number	02.211.010
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional classification code: hrs.Explant date is not applicable since it is still implanted in patient.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 manufacture date is unknown.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 the patient underwent an open reduction internal fixation (orif) left distal humerus fracture on (b)(6) 2018.During the procedure, the measurement of the depth gauge for screws was 5mm which was too short.A second set was opened for another depth gauge and the surgeon expressed the same problem with the second one.It was also reported that the three (3) variable angle (va) locking screws were wasted.All three screws were remeasured to confirm length.The va locking screw would not lock into the most distal-lateral hole of the plate.The surgeon tried to remove it but the screw just spun in the locking hole without retracting out.The surgeon continued to implant the plate because the reduction and the rest of the fixation were good.The screw was also remained implanted because it would not get out without taking the plate off.There were 5-10 minutes of surgical delay.The patient outcome was stable.Concomitant devices reported: unknown variable angle locking screws (part # unknown, lot # unknown, quantity 3) this is report 1 of 2 for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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.

• Brand Name: 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 10MM
• 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: 7658623
• Report Number: 2939274-2018-52698
• Device Sequence Number: 2063501
• Product Code: HWC
• UDI-Device Identifier: 10886982053541
• UDI-Public: (01)10886982053541
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K103243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2018

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: 02.211.010
• Device Catalogue Number: 02.211.010
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/03/2018
• Supplement Report FDA Received Date: 07/05/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(6) 2018; SEE DESCRIPTION, (B)(6) 2018
• Patient Age: 18 YR
• Patient Weight: 103