MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 3.5/4.5MM VA PPFX PROX FEMUR PLATE/10HOLES/LEFT; PLATE, FIXATION, BONE

Model Number 02.221.123

Device Problem Material Twisted/Bent (2981)

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

Event Date 05/10/2022

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Therapy date (b)(6) 2022.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 (b)(6) 2022, 5.0 va locking screw would not thread into the plate in two of the distal interlocking holes.The correct drill guide and drill bit were used to prepare for insertion but screws stripped out in both holes.Another plate was placed with same screws with no issue.There was no reported surgical delay.There were no patient consequences.This report involves (1) 3.5/4.5mm va ppfx prox femur plate/10holes/left.This is report 1 of 3 for (b)(4).

• Brand Name: 3.5/4.5MM VA PPFX PROX FEMUR PLATE/10HOLES/LEFT
• Type of Device: PLATE, FIXATION, BONE
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• Manufacturer (Section G): WERK MEZZOVICO (CH); via cavazz 5; mezzovico 6805 ; SZ 6805
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 14622153
• MDR Text Key: 293475921
• Report Number: 2939274-2022-02114
• Device Sequence Number: 1
• Product Code: HRS
• UDI-Device Identifier: 10886982275745
• UDI-Public: (01)10886982275745
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210205
• 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: 06/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02.221.123
• Device Catalogue Number: 02.221.123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2022
• 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: 5.0 MM VA LOCKING; UNK - SCREWS: 5.0 MM VA LOCKING; UNK DRILL GUIDE