MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP POSTLAT DHP-LAT SUPT 4H/LT/88MM-MED; PLATE,FIXATION,BONE

Model Number 02.117.104

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Not Applicable (3189)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

Additional classification code: hwc.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 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 2 of 2 for (b)(4).

• Brand Name: 2.7MM/3.5MM VA-LCP POSTLAT DHP-LAT SUPT 4H/LT/88MM-MED
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK RARON (CH); kanalstrasse west 30; raron
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7658612
• MDR Text Key: 113028377
• Report Number: 2939274-2018-52697
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982035905
• UDI-Public: (01)10886982035905
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120717
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.117.104
• Device Catalogue Number: 02.117.104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SEE DESCRIPTION, (B)(6) 2018
• Patient Age: 18 YR
• Patient Weight: 103