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

Device Problem Device-Device Incompatibility (2919)

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

Event Date 01/19/2022

Event Type  malfunction  

Manufacturer Narrative

This report is for an unknown plates: trauma/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.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 (b)(6) 2022, the patient underwent the removal surgery of the tomofix plate for the proximal tibia.During the surgery, the surgeon could not remove the screws with the screwdriver.The surgeon replaced the handle with a t-handle which belonged to the hospital and tried to remove the screws, but the head of the screws stripped.The surgeon used the extraction screw; however, the tip of the extraction screw broke.The surgeon was able to remove the screws by chipping the head of the screws with the carbide drill and cut off from the plate.The surgery was completed successfully within 30 minutes delay.No fragments remain in the patient.The patient was reported as stable.This report involves one (1) unknown plates: trauma.This is report 4 of 4 for (b)(4).

• Brand Name: UNK - PLATES: TRAUMA
• 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: 13552428
• MDR Text Key: 291614192
• Report Number: 8030965-2022-00972
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/19/2022
• Initial Date FDA Received: 02/17/2022
• 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: EXTRACT-SCREW CONI F/SCR Ø4.5+6.5; SCRDRIVERSHAFT-3.5-HEX SELF-HOLD; UNK - SCREWS: TRAUMA