MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC TI LCP(TM) DISTAL FEMUR PLATE 11 HOLES/276MM-RIGHT; PLATE, FIXATION, BONE

Model Number 422.256

Device Problems Device-Device Incompatibility (2919); Migration (4003)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.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 a procedure on an unknown date, the screws either backed out or were broken.The patient was revised with another plate.Procedure was with an unknown delay.Patient outcome is unknown.This report is for a titanium (ti) locking compression plate (lcp) distal femur plate.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: the complaint condition was not confirmed for the ti lcp(tm) dstl femur pl 11 holes/276-rt (p/n: 422.256 & lot #: l658013).During the investigation, no product design issues or discrepancies were observed.No manufacturing issues were noted during investigation.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Therefore, it has been determined that no corrective and/or preventive action is proposed.Device history lot : as per jde, the manufactured date for device is 10-jan-2018.A manufacturing-related potential cause was not suspected, therefore, per franchise complaint product investigation procedure 100673626 no manufacturing record evaluation is required.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: TI LCP(TM) DISTAL FEMUR PLATE 11 HOLES/276MM-RIGHT
• 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: 12205073
• MDR Text Key: 264507112
• Report Number: 2939274-2021-04195
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982215444
• UDI-Public: (01)10886982215444
• Combination Product (y/n): N
• PMA/PMN Number: K062564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 422.256
• Device Catalogue Number: 422.256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Date Manufacturer Received: 08/19/2021
• Patient Sequence Number: 1
• Treatment: 5.0 TI LOCKING SCREW SELF-DRILLING 40
• Patient Age: 79 YR
• Patient Weight: 123