MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MM; PLATE,FIXATION,BONE

Model Number 02.107.302

Device Problem Failure to Align (2522)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2018

Event Type  malfunction  

Manufacturer Narrative

Patient weight was not provided for reporting.Additional device product code: hwc.Implant date: device remained implanted.Device explant date is not applicable.Device is not expected to be returned for manufacturer review/investigation as device remained implanted.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Additionally, device history records review could not be completed without lot number.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 on (b)(6) 2018, patient underwent procedure for an open reduction internal fixation (orif) olecranon fracture.During the procedure, a locking screw would not lock into the left olecranon plate.The surgeon tried to insert the screw in on power then switched to manual, but was still unsuccessful.The interface between the plate and screw did not lock into the plate.There was a two-minute surgical delay to obtain another of the same screw which was inserted in a different hole in the plate.The plate and ten (10) screws were implanted.The surgery was successfully completed.The patient outcome was as expected.Concomitant devices reported: power screwdriver (part# unknown, lot# unknown, quantity 1).Screwdriver (part# unknown, lot# unknown, quantity 1).This report is for one (1) 2.7mm/3.5mm va-lcp olecranon pl 2h/lt/90mm.This is report 1 of 2 for (b)(4).

• Brand Name: 2.7MM/3.5MM VA-LCP OLECRANON PL 2H/LT/90MM
• 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): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: michael cote ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 7385138
• MDR Text Key: 104268723
• Report Number: 2939274-2018-51351
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982029331
• UDI-Public: (01)10886982029331(10)LOT#UNKNOWN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.107.302
• Device Catalogue Number: 02.107.302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 64 YR