MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5MM LCP OLECRANON PLATE 6 HOLES/RIGHT/138MM; APPLIANCE,FIXATION,NAIL

Model Number 236.506

Device Problem Break (1069)

Patient Problems Pain (1994); Skin Erosion (2075); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr, manufacture date: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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.(b)(4).

Event Description

This report is against user facility medwatch number (b)(4).The only information contained in this report is correction or additional information.Concomitant device reported: unk - screws: trauma (part # unknown, lo # unknown, quantity # 9), unk - guide/compression/k-wires (part #: unknown, lot # unknown, quantity # unknown) & unk - synthes no further info: trauma (part # unknown, lot # unknown, quantity # unknown).This report is for one (1) 3.5mm lcp olecranon plate 6 holes/right/138mm.This is report 1 of 1 for complaint (b)(4).

• Brand Name: 3.5MM LCP OLECRANON PLATE 6 HOLES/RIGHT/138MM
• Type of Device: APPLIANCE,FIXATION,NAIL
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 8746126
• MDR Text Key: 149629376
• Report Number: 2939274-2019-58920
• Device Sequence Number: 1
• Product Code: KTT
• UDI-Device Identifier: 10886982160737
• UDI-Public: (01)10886982160737
• Combination Product (y/n): N
• PMA/PMN Number: K000684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 236.506
• Device Catalogue Number: 236506
• Date Manufacturer Received: 06/03/2019
• 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