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

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

Patient Problems Bone Fracture(s) (1870); Inflammation (1932); Pain (1994); Loss of Range of Motion (2032); Impaired Healing (2378)

Event Date 12/05/2022

Event Type  Injury  

Event Description

Device report from china reports an event as follows: post-op inflammation.This case is from the health authority.It was reported that last march, the patient suffered a fracture of the left tibial plateau due to trauma and was hospitalized for surgical treatment.The existing internal fixation was kept in the hospital.After surgery, the knee joint suffered from pain and discomfort.Six months later, the patient was hospitalized for treatment.After symptomatic treatment, the patient was discharged.After discharge, the patient complained that the pain had worsened, and still could not walk for a long time.The patient could be relieved by lying in bed.Now, the surgical healing scar at the proximal end of the lower leg can be seen; in may of this year, there was no obvious inducement to find a mass in the front of the middle segment of the left calf, about 3cm in diameter, with slight tenderness.Due to lack of attention, the patient later complained that the mass was gradually increasing, and the left knee joint movement was partially limited.He was hospitalized in the local hospital four months later, and the culture of puncture secretions showed negative.Considering that the patient was in pregnancy, the patient refused to remove the mass temporarily, requiring conservative treatment, and further diagnosis and treatment after delivery, one month after delivery, the local tumor of the patient is about 10 * 20cm.There are blood vessels out of shape on the surface, the skin temperature is slightly high, and the tumor is pushed to be immovable, the texture is slightly hard.It is required to remove the tumor, improve the nucleic acid detection of covid-19, and today it is included in our department for further treatment.This report is for an unk - screw: trauma.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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.This report is for an unknown screw: trauma/unknown lot.Part and lot numbers are unknown; udi 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.

• Brand Name: UNK - SCREWS: TRAUMA
• Type of Device: SCREW, FIXATION, BONE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16148332
• MDR Text Key: 307197299
• Report Number: 8030965-2023-00465
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2022
• 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: LCP MED PROX-TIBPL 4.5 LE SHAFT 10HO L21
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Sex: Female