MAUDE Adverse Event Report: SYNTHES GMBH 5.0MM SELF-DRILLING SCHANZ SCREW 175MM/HA COATING-STERILE; SCREW, FIXATION, BONE

Model Number 294.785SHA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Sepsis (2067)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in switzerland as follows: it was reported that the patient underwent surgery for the correction of bony or soft tissue deformities.This was the primary surgery.Ha schanz screws were used in conjunction with maxframe.The patient experienced a postoperative infection at the operative site two months after surgery.This led to a below the knee amputation secondary to septicemia.No further information is available.This report involves one 5.0mm self-drilling schanz screw 175mm/ha coating-sterile.This is report 2 of 2 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.Additional narrative: date of event: only the event year is known.Procode: additional device product codes: ktt.Device available for evaluation: complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: reporter is a j&j employee.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.

• Brand Name: 5.0MM SELF-DRILLING SCHANZ SCREW 175MM/HA COATING-STERILE
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16088089
• MDR Text Key: 306543050
• Report Number: 8030965-2023-00055
• Device Sequence Number: 1
• Product Code: HWC
• UDI-Device Identifier: 10886982182180
• UDI-Public: 10886982182180
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161417
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 294.785SHA
• Device Catalogue Number: 294.785SHA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2023
• 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 - MAXFRAME
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male