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 Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

Additional procode: 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.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.

Event Description

It was reported that during an unknown procedure on (b)(6) 2020, an unknown locking screw wouldn't lock into the most proximal screw holes of the reported variable angle locking compression plate (va-lcp) olecranon plate.The procedure was completed by leaving the locking screw in the screw hole unlocked.There was a 2 minute surgical delay reported.Patient status is unknown.This complaint involves 2 devices.This report is for 1 2.7mm/3.5mm va-lcp olecranon pl 2h/lt/90mm.This is report 1 of 2 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in 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.

• 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
• MDR Report Key: 10171840
• MDR Text Key: 195752345
• Report Number: 2939274-2020-02889
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982029331
• UDI-Public: (01)10886982029331
• Combination Product (y/n): N
• PMA/PMN Number: K120070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• 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
• Date Manufacturer Received: 06/21/2020
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: LOCKING