MAUDE Adverse Event Report: SYNTHES GMBH 6.5 TI CANNULATED SCREW 16 THREAD 50; SCREW, FIXATION, BONE

Catalog Number	408.405
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Nonunion/Delayed-union Bone Fracture (2369); Post Operative Wound Infection (2446); Physical Asymmetry (4573)
Type of Reportable Event	Serious Injury
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.Additional narrative: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
This complaint is from a literature source.The following literature cite has been reviewed: zhao j., chen cs, xu zh, chen hf, zhang f, wang qp, zhou jl, que yd, comparison of femoral neck internal fixation system and simple connulated screw internal fixation in the treatment of femoral neck fractures in patients under 65 years old, zhongguo zuzhi gongcheng yanjiu.2023; 27(36):5823-5827.Objective/methods/study data: this study was a retrospective case analysis aiming to observe the effect of a new type of femoral neck internal fixation system in the treatment of femoral neck fractures.Between january 2019 to june 2020, a total of 53 patients (24 male and 29 female) with a mean age of 45.75 years were included in the study.These patients had femoral neck fractures and underwent surgery where 21 of them were fixed with femoral neck system (depuy synthes) or referred as the observation group; and 32 patients were fixed with cannulated screws (depuy synthes) or the control group.All patients were followed up for 12-24 months after surgery.Lot, model and catalog number are not available, but the suspected depuy synthes device(s) possibly associated with reported adverse events: unk - constructs: fns and 408.405 (cannulated screws) adverse event(s) and provided interventions possibly associated with unk - constructs: fns (qty (b)(4): observation group (fns) - (n=1) delayed fracture healing treatment: not reported - (n=3) femoral neck shortening treatment: not reported - (n=1) femoral head necrosis treatment: not reported.Adverse event(s) and provided interventions possibly associated with 408.405 (cannulated screws) (qty (b)(4): control group (cannulated screws) - (n=1) infection of incision treatment: underwent active dressing change in the late stage and the incision healed - (n=8) femoral neck shortening treatment: not reported - (n=1) fracture nonunion treatment: not reported - (n=5) femoral head necrosis treatment: not reported.
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.H6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Investigation summary: product was not returned.Based on the information available, it has been determined that no corrective and 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 6.5 TI CANNULATED SCREW 16 THREAD 50
• Common Device Name: 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: 21094459
• Report Number: 8030965-2025-00215
• Device Sequence Number: 8657118
• Product Code: HWC
• UDI-Device Identifier: 10886982208873
• UDI-Public: (01)10886982208873
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 408.405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown