MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM/3.5MM VA-LCP MEDL DSTL HUMERUS PL 6H/LT/134MM-XLONG; PLATE,FIXATION,BONE

Model Number 02.117.506

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.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, there was a hardware removal of va-lcp posterolateral distal humerus plate, va lcp medial distal humerus plate, and unknown screws.Removal was due to broken plate and screws.Procedure and patient outcome were unknown.This complaint involves six (6) devices.This report is for (1)2.7mm/3.5mm va-lcp medial distal humerus pl 6h/lt/134mm-xlong.This report is 3 of 6 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: product complaint (b)(4).Investigation summary : product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot : part: 02.117.506.Lot: 9612665.Manufacturing site: mezzovico.Release to warehouse date: 24.August 2015.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.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 MEDL DSTL HUMERUS PL 6H/LT/134MM-XLONG
• 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: 11127185
• MDR Text Key: 225574731
• Report Number: 2939274-2021-00040
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982036827
• UDI-Public: (01)10886982036827
• 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: 12/11/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.117.506
• Device Catalogue Number: 02.117.506
• Device Lot Number: 9612665
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/11/2020
• Initial Date FDA Received: 01/06/2021
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/27/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention