MAUDE Adverse Event Report: SYNTHES GMBH TFNA FENESTRATED SCREW 100MM - STERILE; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number	04.038.200S
Medical Device Problem Codes	Break (1069); Migration (4003)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	03/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint (b)(4).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.H10 additional narrative: d2b.Additional pro-code: ktt.D9: complainant part is not expected to be returned for manufacturer review/investigation.E1: legal h3,h6: device history lot.Part # 04.038.200s.Synthes lot # h750414.Supplier lot # n/a.Release to warehouse date:25 oct 2018.Manufactured by: synthes elmira.No ncrs were generated during production.Device history batch null.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.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.
Event or Problem Description
This is a legal complaint it was reported that on (b)(6) 2020 the patient brought to the er with the left hip pain after a fall.On (b)(6) 2020, the patient underwent cephalomedullary fixation of left peritrochanteric femur fracture.On (b)(6) 2020, she reports soreness and a popping sensation whenever she flexes her hip.Soreness and pain whenever she does any abduction movements.Dexa scan showing osteoporosis.On (b)(6) 2021, ct scan of the hip shows a small crack in the lag screw.There is bony callus formation over the broken screw.On (b)(6) 2022, she had developed a very prominent lag screw from her cephalomedullary nail.Of note the tip of the lag screw had broken.On (b)(6) 2022, the patient underwent left femur removal of hardware and left subtrochanteric femur delayed-union repair with exchange of cephalomedullary nail.This complaint involves one (1) devices.This report is for one (1) tfna fenestrated screw 100mm - sterile.This is report 1 of 1 for complaint (b)(4).

• Brand Name: TFNA FENESTRATED SCREW 100MM - STERILE
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): ELMIRA; 35 airport road; horseheads NY 14845
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 16818626
• Report Number: 8030965-2023-05320
• Device Sequence Number: 1842222
• Product Code: HSB
• UDI-Device Identifier: 10886982098771
• UDI-Public: (01)10886982098771
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K160167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 04.038.200S
• Device Catalogue Number: 04.038.200S
• Device Lot Number: H750414
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 04/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2018
• 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: 11/130 DEG TI CANN TFNA 360/LEFT - SILE.; 2.5 REAMING ROD BALL TIP/950-STERILE.; 5.0 TI LCKNG SCREW T25 SD 40 F/IM NAIL-S.; 5.0 TI LCKNG SCREW T25 SD 44 F/IM NAIL-S.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female