MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP PROXIMAL OLECRANON PL 2H/RT/73MM; PLATE,FIXATION,BONE

Model Number 02.107.002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Joint Contracture (4528)

Event Type  Injury  

Manufacturer Narrative

Additional product code: hwc.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 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.(b)(4).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) 2020, the patient underwent for a hardware removal of right olecranon surgery due to malunion.There was no surgical delay reported.The procedure was successfully completed.The patient outcome was stable.This complaint involves eight (8) devices.This report involves one (1) 2.7mm/3.5mm va-lcp proximal olecranon pl 2h/rt/73mm.This report is 1 of 8 for (b)(4).

• Brand Name: 2.7MM/3.5MM VA-LCP PROXIMAL OLECRANON PL 2H/RT/73MM
• 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): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11189075
• MDR Text Key: 227753209
• Report Number: 2939274-2021-00337
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982029225
• UDI-Public: (01)10886982029225
• 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: Physician
• Type of Report: Initial
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 02.107.002
• Device Catalogue Number: 02.107.002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2020
• Initial Date FDA Received: 01/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention