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
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: PLATE,FIXATION,BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10421333
• Report Number: 2939274-2020-03606
• Device Sequence Number: 2975834
• Product Code: HRS
• UDI-Device Identifier: 10886982168450
• UDI-Public: (01)10886982168450
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K091644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/24/2020

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: 242.467
• Device Catalogue Number: 242.467
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/18/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 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