MAUDE Adverse Event Report: SYNTHES GMBH UNK - KITS/SETS: FNS IMPLANT KIT; ORTHOSIS,PEDICLE,SPINAL FIXATION

Catalog Number UNK - KITS/SETS: FNS IMPLANT K

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ambulation Difficulties (2544); Physical Asymmetry (4573)

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.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.This report is for an unknown device/unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.The lot number was unknown.Therefore, the expiration date and device manufacture date were unknown.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 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.

Event Description

This report is being filed after the review of the following journal article: kobayashi h, et al.(2021), case study of excessive telescoping after osteosynthesis for non-displaced femoral neck fractures, orthopedics & traumatology, volume 70, number 3, pages 474-477 (japan).The purpose of this study is to investigate cases with excessive telescoping as a poor prognosis group and consider the factors that contribute to it.Between january 2017 and may 2020, 28 patients who underwent osteosynthesis for non-displaced femoral neck fractures were included in the study.There were 7 males and 21 females with a mean age of 79.0 ± 11.3 years.The type of device used was an unknown synthes femoral neck system in 6 patients, a competitor¿s pin in 15 patients, and a competitor¿s plate in 7 patients (multiple pinning in 3 patients, a side plate short in 3 patients, and a side plate long in 1 patient).The patients were divided 2 groups: a group of 5 patients in which 6 mm or more of telescoping was seen within 3 months after surgery (hereinafter referred to as the excessive telescoping group) and a group of 23 patients with telescoping of less than 6 mm (hereinafter referred to as the normal group).The mean observation period was 10.4 months (3 to 29 months).The authors did not specify which of the patients who experienced complications were implanted with a synthes device.Thus, complications will be reported as follows: unknown patients had excessive telescoping.Unknown patients had an artificial head replacement.Unknown patients had a postoperative decline in walking ability.This report is for the unknown synthes femoral neck system.

• Brand Name: UNK - KITS/SETS: FNS IMPLANT KIT
• Type of Device: ORTHOSIS,PEDICLE,SPINAL FIXATION
• 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: 14498889
• MDR Text Key: 294405026
• Report Number: 2939274-2022-01922
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK - KITS/SETS: FNS IMPLANT K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention