MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH UNK - SCREWS: CORTEX; SCREW,FIXATION,BONE

Device Problems Device Slipped (1584); Unintended Movement (3026); Migration (4003)

Patient Problem No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

This report is for an unk - screws: cortex/unknown lot.Part and lot numbers are unknown; udi number is unknown.(b)(4).The investigation could not be completed; no conclusion could be drawn, as no product was received.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.Without a lot number the device history records review could not be completed.Product was not returned.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) 2019, the patient underwent a surgery for lisfranc joint fracture with the va-foot system and two locking screws issue.On (b)(6) 2019, the patient underwent the removal surgery due to bone union and the cortex screw loosening.During the removal surgery, the surgeon found that two locking screws had been broken at their necks.They are removed with a chisel and one locking screw was discarded.The surgery was delayed by 90 minutes.Concomitant devices reported: unknown cutting instruments: chisel: trauma (part# unknown, lot# unknown, quantity# 1) unknown plate (part# unknown, lot# unknown, quantity# 1).This is report 3 of 3 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.H3, h6: the complaint condition that the screw backed out could be confirmed according to the received x-rays.Product was not returned.Based on the information available, it has been determined that no corrective and 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

Concomitant devices: plate (part: unknown, lot: unknown, quantity: 1).

• Brand Name: UNK - SCREWS: CORTEX
• Type of Device: SCREW,FIXATION,BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9419098
• MDR Text Key: 185493792
• Report Number: 8030965-2019-70850
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/16/2019
• Patient Sequence Number: 1
• Treatment: UNK - CUTTING INSTRUMENTS: CHISEL: TRAUMA; UNK - PLATES; UNK - PLATES
• Patient Outcome(s): Required Intervention