MAUDE Adverse Event Report: SYNTHES GMBH UNK - ZIPFIX IMPLANTS; CERCLAGE, FIXATION

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

Patient Problem Bacterial Infection (1735)

Event Date 02/03/2022

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.This report is for an unknown zipfix implant/unknown lot.Part and lot numbers are unknown; udi number is unknown.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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial, a follow-up will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: tam jkc, et al.(2022), novel nuss bar fixation using zipfix for pectus excavatum, heart, lung and circulation, 31, 889¿893, https://doi.Org/10.1016/j.Hlc.2021.12.012, (singapore).This study reports on a novel method of bar fixation using zipfix, a biocompatible cable-tie implant, and shares a series of patients and outcomes.Between july 2015 and september 2020, 20 patients with significant pectus excavatum who underwent a nuss procedure with zipfix were included in this study.There were 19 males and 1 female, and the mean age of all patients was 22 years (range, 16¿38).The patients underwent nuss bar procedure and were implanted with a competitor¿s nuss bar (manufacturer: unknown) that were stabilized using the unknown synthes zipfix.6 patients had 1 zipfix placed and 14 patients had 2 zipfix implanted.As per institution practice, the bar and zipfix are removed 2¿3 years after the implantation.Complications were reported as follows: patient 4, a 23-year-old male had bilateral wound dehiscence after removal requiring left vacuum-assisted drainage and secondary closure.Patient 11, a 19-year-old male had (2) zipfix on right developed left empyema requiring drainage and decortication.Patients 12, a 19-year-old male had post implantation right superficial wound infection which was conservatively managed.This report is for an unk - zipfix implant.This is report 3 of 3 for (b)(4).

• Brand Name: UNK - ZIPFIX IMPLANTS
• Type of Device: CERCLAGE, 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: 16311876
• MDR Text Key: 308945065
• Report Number: 8030965-2023-01479
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: 02/07/2023
• 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: 01/16/2023
• 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
• Patient Sex: Male