MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP EXT MEDL DSTL HUM PL 4H/LT/111MM-LONG; PLATE, FIXATION, BONE

Model Number 02.117.704

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Additional device product code: hwc.Reporter is a j&j sales representative.(b)(4).The device has been received, the investigation is in progress, 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 that on (b)(6) 2020, the patient underwent a revision procedure due to a broken variable angle-locking compression (va-lcp) distal humeral plate.Initially, the patient was implanted with the reported device 3 weeks ago.During the revision procedure, the broken plate was removed and the patient was revised to another plate.It is unknown if there was a surgical delay.Patient status and surgical outcome were unknown.Concomitant device reported: unknown screws (part # unknown, lot # unknown, quantity 10).This report is for 1 2.7mm/3.5mm va-lcp ext medl dstl hum pl 4h/lt/111mm-long.This is report 1 of 1 for complaint (b)(4).

Event Description

Updated concomitant device reported: screws (part unknown, lot unknown, quantity 5), va locking screw (part 02.211.050, lot unknown, quantity 1), va locking screw (part 02.211.018, lot unknown, quantity 1), va locking screw (part 02.211.020, lot unknown, quantity 1), va locking screw (part 02.211.028, lot unknown, quantity 1).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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10: additional narrative: h3, h4, h6: part 02.117.704, lot l816876: manufacturing site: mezzovico.Release to warehouse date: march 14, 2018.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.H3, h6: a product investigation was completed: upon visual inspection, it was observed that the plate was broken.No other defects were identified on the device.No dimensional inspection was performed due to confirmed post manufacturing defect.The relevant drawing was reviewed.The complaint condition is as the plate was broken across one of the hole.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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 EXT MEDL DSTL HUM PL 4H/LT/111MM-LONG
• 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: 10862059
• MDR Text Key: 216942309
• Report Number: 2939274-2020-05211
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982037220
• UDI-Public: (01)10886982037220
• 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
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.117.704
• Device Catalogue Number: 02.117.704
• Device Lot Number: L816876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Date Manufacturer Received: 12/03/2020
• Patient Sequence Number: 1
• Treatment: 2.7MM VA LOCKING SCREW 18MM.; 2.7MM VA LOCKING SCREW 20MM.; 2.7MM VA LOCKING SCREW 22MM.; 2.7MM VA LOCKING SCREW 28MM.; 2.7MM VA LOCKING SCREW 50MM.; UNK - SCREWS: TRAUMA.; UNK - SCREWS: TRAUMA.; UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention