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

Catalog Number UNK - SCREWS: TRAUMA

Device Problem Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).This report is for an unknown screws: trauma/unknown lot number.Without the specific part number, the udi number and 510k 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 as no product was received.The investigation could not be completed; no conclusion could be drawn at the time of filing this report.Investigation summary 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: the patient had a second intervention on september 13, during which osteosynthesis was performed with an anatomical clavicle plate; but the osteosynthesis material became infected and loosened again, dr.(b)(6) decided to remove the material, wash, debride and close.In the institution they send the material to an internal process called sonication, it was not returned or sent to quality, the client does not require a response.This complaint involves four (4) devices.This report is 4 of 4 for (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.Date of implant: (b)(6) 2019.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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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

On (b)(6) 2019, the patient diagnosed with a bilateral sternoclavicular dislocation underwent an osteosynthesis with a sternum plate, the surgeon decided on that occasion to place the plate safety hook upside down, which caused the system to loosen.On (b)(6) 2019, this osteosynthesis material was removed at the institution, they send the extracted material to an internal process called sonication, it is not returned or sent to quality, the client does not demand a response and the sternoclavicular dislocation fixation was performed again bilateral with anatomical bilateral clavicle plate, this material again failed, became infected and loosened, the surgeon decided to remove the material, wash, debride and close, in the institution they send the extracted material to an internal process called sonication, it is not returned or it is sent to quality, the client does not demand a response either.Finally, on (b)(6) 2020, the patient is reoperated again.The surgeon decides to do anatomical reduction with an x-shaped polyester suture, the procedure was performed in the company of the institution's thorax surgeon.

• Brand Name: UNK - SCREWS: TRAUMA
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 9253120
• MDR Text Key: 180125944
• Report Number: 8030965-2019-69797
• 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,Followup
• Report Date: 10/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - SCREWS: TRAUMA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention