MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC LCP VOLAR DISTAL RADIUS PLATE EXTRA-ARTICULAR 4H HEAD-LEFT PLATE,FIXATION,BONE

Model Number 242.467

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Reporter is jnj representative. Without a lot number, the device history records review could not be completed as no product was received. The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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.

Event Description

It was reported on an unknown date, the locking compression plate (lcp) volar distal radius plate was noticed bent, an unknown screw was not attaching correctly, two (2) unknown guide wires were very rough, tip of the screwdrivers were warped / bent from torque of insertion and the screwdriver handle was not picking up screws correctly as well. The issues were noticed during routine inspection. There was no patient involvement reported. This complaint involves nine (9) devices. This report is for (1) lcp® volar distal radius plate extra-articular 4h head-left. This is report 1 of 3 for (b)(4). Related product complaint: (b)(4).

• Brand Name: LCP VOLAR DISTAL RADIUS PLATE EXTRA-ARTICULAR 4H HEAD-LEFT
• 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: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 10421333
• MDR Text Key: 203365694
• Report Number: 2939274-2020-03606
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 242.467
• Device Catalogue Number: 242.467
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown

Patient Treatment Data

Date Received: 08/18/2020 Patient Sequence Number: 1

Treatment

CANNULATED 4.0MM HEXAGONAL SCREWDRIVER; STARDRIVE SCREWDRIVER SHAFT T8 105MM; STARDRIVE(TM) SCREWDRIVER T15; STDRV SCRWDR SFT SD6/SLF-RETING/2.0MM; UNK - GUIDE/COMPRESSION/K-WIRES; UNK - SCREWS: TRAUMA