MAUDE Adverse Event Report: SYNTHES GMBH UNK - PLATES: LCP DISTAL FIBULA PLATE; PLATE, FIXATION, BONE

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981)

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

Event Date 01/01/2022

Event Type  malfunction  

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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.Additional narrative: event occurred at an unknown date in 2022.This report is for an unknown plate: lcp distal fibula plate/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter is a synthese 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 on an unknown date the surgical team was using the titanium 2.7/3.5 va-lcp distal fibula plate 5 hole right.When it was time to start filling the distal cluster, the locking mechanism was not engaging with the va screws - 4 of the screw holes were not engaging.Due to the patient¿s bad bone quality the screws were prevented from backing out, causing them to spin in the screw hole.With four of the screws being in and not being bicortical, little fixation in the distal fragment was achieved.The surgeon looked to be within the 15 degree ratio, was using the correct drill guide, correct va screws, and correct drill.This report is for an unk - plate: lcp distal fibula plate.This is report 1 of 1 for (b)(4).

• Brand Name: UNK - PLATES: LCP DISTAL FIBULA PLATE
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15633038
• MDR Text Key: 306798016
• Report Number: 8030965-2022-08438
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - DRILL BITS: TRAUMA; UNK - SCREWS: TRAUMA; UNK - SCREWS: VA LOCKING