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

Device Problem Material Twisted/Bent (2981)

Patient Problem Failure of Implant (1924)

Event Date 01/03/2023

Event Type  Injury  

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: fns locking/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.

Event Description

This report is being filed after the review of the following journal article: yoon, j.Y., byun, s.E.And cho, y.H.(2022).Fixation of femoral neck fracture with femoral neck system: a retrospective cohort study of 43 patients., research square, vol.X (xx) pages 1-10, (south korea).The aim of this retrospective cohort study was to discuss the initial experience of using a new fixation device (fns) and evaluate the radiological complications, such as nonunion, osteonecrosis, and screw cut-out.Furthermore, despite the small number of study participants, they identified several statistically significant factors related to surgical failure.Between july 2019 and june 2021, a total of 43 patients [ 25 females and 18 males with mean age of 62.1 (range: 57.7¿66.5) years] underwent osteosynthesis using fns (femoral neck system) during the study period were included in the analysis.The median clinical follow-up period was 11.8 months (range: 10.1¿13.4).The following complications were reported as follows: 4 patients complained of residual pain in the affected hip at the final follow-up, and 6 presented with limping gaits.All 4 patients later underwent arthroplasty due to serious complications during follow-up as mentioned below the following: - 48 years old, female patient who had femoral neck fracture (fnf) with underlying moderate-grade intellectual, underwent revision surgery due to nonunion.The patient was diagnosed with garden type 4 fnf (femoral neck fracture), and the bone quality was poor due to general medical conditions.- 59 years old, male, underwent revision surgery due to nonunion.- 55 years old, male, who underwent revision surgery due to bolt cutout.- 78 years old, male, who underwent revision surgery due to post-traumatic osteoarthritis for the reason of osteonecrosis.After the complete bone union was confirmed, 5 patients (mean age, 43.8 years; mean bmi, 23.1 kg/m2; female: male ratio = 2:3) underwent additional surgery for implant removal, and the mean duration between initial surgery and implant removal was 17.6 (range: 14.7¿18.9) months.During the implant removal procedure, distal locking screw stripping occurred in 3 patients.The implant could only be removed after forced metal plate cutting with a hercules plate cutter or saw due to screw breakage, but implants were successfully removed from all the patients.No acute perioperative complications were observed during admission, except in 2 cases that showed short-term postoperative delirium.However, the delirium subsided within 3 days, and both patients were successfully discharged from the hospital after rehabilitation.No postoperative infections were noted during the follow-up period.- another case of an implant removal failure of a 61-year-old female patient that due to a jammed locking screw, the plate had to be cut in half using a metal cutting saw (arrowheads) to get it removed from the patient and stripping of the internal hexagon in the head of a locking screw (arrow) occurred easily.The screw and the remaining plate were easily pulled out together, and no screw shank fracture occurred.This report is for an unk - screw: fns locking.This is report 1 of 8 for (b)(4).

• Brand Name: UNK - SCREWS: FNS LOCKING
• 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: 16247359
• MDR Text Key: 308179937
• Report Number: 8030965-2023-00975
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,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: 01/26/2023
• 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: 01/06/2023
• 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
• Patient Outcome(s): Other