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

Device Problem Device-Device Incompatibility (2919)

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

Event Date 03/05/2021

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown plates/unknown lot.Part and lot numbers are unknown.Udi number is unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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

Device report from synthes reports an event in (b)(6) as follows: it was reported that on an unknown date, the patient underwent the implant surgery with the plate and screw.After the surgery, the patient fell and experienced a fracture.On (b)(6) 2021, the patient underwent the revision surgery replacing the plate.In the revision surgery, the surgeon had difficulty in removing the screw because the screw was stuck into the plate.The surgeon could not remove the screw from the plate, and the surgeon removed the screw and plate together with a pliers.The surgery was completed successfully with a thirty (30) minute delay.This product complaint (pc) related to (b)(4) which reports about the fracture after the surgery.This pc reports about the screw stuck in the revision surgery on (b)(6) 2021.This report involves one (1) unknown plates.This is report 2 of 2 for (b)(4).

• Brand Name: UNK - PLATES
• Type of Device: PLATE,FIXATION,BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11602066
• MDR Text Key: 245839325
• Report Number: 8030965-2021-02509
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2021
• 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: 03/05/2021
• 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