MAUDE Adverse Event Report: SYNTHES GMBH 3.5MM CORTEX SCREW 80MM; SCREW, FIXATION, BONE

Catalog Number	204.080
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
1it was reported on (b)(6) 2024 the patient had a hardware removal due to broken ulna above implant.Patient and surgical status unknown.Original implant date not known.This report is for one 3.5mm cortex screw 80mm.This is report 4 of 8 for (b)(4).This complaint is linked to (b)(4) for additional impacted products.
Additional 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.B3: unknown when fracture occurred.H3, h6 photo investigation two (2) photos were returned to depuy synthes for evaluation.A visual inspection of the photos, found that they are ap and lateral x-rays of a left forearm that has a plate and screw construct on both the radius (plate with 6 screws) and the ulna (plate with 10 screws) and that both bones had fractured at the proximal ends of the plates.There is no evidence of an issue with any of the devices visible in the x-rays.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as it can be seen in the x-rays provided that the bones are broken.The investigation did not identify an issue with the 3.5mm cortex screw 80mm and there is no indication that a design or manufacturing issue has contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history the device lot number is unknown, therefore a device history review could not be performed.If the lot/serial number becomes available, the record will be re-assessed.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: 3.5MM CORTEX SCREW 80MM
• Common Device Name: 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: 19515705
• Report Number: 8030965-2024-07347
• Device Sequence Number: 6216635
• Product Code: HWC
• UDI-Device Identifier: 10886982145680
• UDI-Public: (01)10886982145680
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K112583
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 204.080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2.7MM CORTEX SCREW 80MM; 2.7MM CORTEX SCREW 80MM; 3.5MM CORTEX SCREW 80MM; 3.5MM CORTEX SCREW 80MM; 3.5MM CORTEX SCREW 80MM; 3.5MM CORTEX SCREW 80MM; 3.5MM CORTEX SCREW 80MM; 3.5MM CORTEX SCREW 80MM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 15 YR
• Patient Sex: Female