MAUDE Adverse Event Report: SYNTHES GMBH UNK - SCREWS: 3.5 MM CORTEX; SCREW, FIXATION, BONE

Device Problem Break (1069)

Patient Problem Bone Fracture(s) (1870)

Event Date 12/29/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022 , patient underwent proximal humerus revision due to broken humerus at the base of the plate (broken humeral shaft).The surgery was successfully completed.Adverse consequence/s that affected the patient because of the reported event let to revision surgery.Broken fragments were retained in patient.It did involved additional intervention to remove retained fragments.There were patient consequences.This report is for one (1) unk - screws: 3.5 mm cortex.This is report 1 of 1 for complaint (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.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: 3.5 MM CORTEX
• 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: 16240192
• MDR Text Key: 308083095
• Report Number: 8030965-2023-00908
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/29/2022
• 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: 3.5 LCP PROXIMAL HUM PL-STD 3H SFT/90; UNK - SCREWS: 3.5 MM LOCKING
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female