MAUDE Adverse Event Report: SYNTHES GMBH UNK - RIA; REAMER

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

Patient Problems Hematoma (1884); Pain (1994)

Event Date 07/31/2022

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: ahmed h.Elhessy., et al (2022)/fusion revision surgery with reamer-irrigator- aspirator to harvest autograft after spinal pseudarthrosis, cureus 14 (7), 1¿11 (usa) this retrospective study is a collaborative study between orthopedic surgery and neurosurgery departments to utilize femur intramedullary autograft harvested using the ria system.Between august 2014 and december 2017, 11 patients who underwent 12 spa revision using the ria system (depuy synthese, west chester, pa) were identified, with females(n=7) and males (n=4).Mean + - standard deviation (sd) of age was 53.7 years (range: 40-62 years).Regarding the levels of presentation, eight cases (66.7%) were lumbosacral, two (16.7%) were lumbar and two (16.7%) were cervical.The time of presentation from the last procedure was 19.9 months (range; 8-36 months).The following complications were reported as follows: 1 patient was infected and did not achieve successful fusion initially; he underwent several debridements to eradicate infection and ended with hardware removal.4 patients (36.4%) had postoperative knee pain.1 patient had a complex meniscal tear on postoperative mri.The last patient with postoperative pain had a tense knee effusion two days after the graft harvesting, which was managed by surgical evacuation of the hematoma.This report is for an unknown synthese reamer-irrigator-aspirator.A copy of the literature article is being submitted with this medwatch.This report is for one (1) unk - ria.This is report 1 of 2 for complaint (b)(4).

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, 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 unk - ria/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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.

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.Initial reporter facility name and address: international center for limb lengthening, rubin institute for advanced orthopedics 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.

• Brand Name: UNK - RIA
• Type of Device: REAMER
• 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: 16613021
• MDR Text Key: 312004666
• Report Number: 8030965-2023-03647
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,Company Representative
• 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

• Date FDA Received: 03/24/2023
• 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: 04/27/2023
• 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): Required Intervention