MAUDE Adverse Event Report: SYNTHES GMBH UNK - REAMERS: SYNREAM

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

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/31/2020

Event Type  Injury  

Manufacturer Narrative

Additional narrative: this report is for an unk reamers: synream/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.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: niikura t., et al (2021) clinical experience of the use of reamer irrigator aspirator in japanese patients: a report of the first 42 cases, journal of orthopaedic science volume 26, pages 459-465 (japan).This retrospective study aims to review the 42 clinical cases and provide information about ria in japanese patients.40 patients (36 men, 6 women; 42 cases) with a mean age of 52.9 (range, 21e86) years in whom reamer irrigator aspirator (ria; depuysynthes, west chester, pa, usa) was used during surgery at our hospital between january 2014 and september 2018 were included in this retrospective review.Intraoperatively, the synream (depuy synthes) reamer head was manually inserted and the diameter of the head increased until resistance was felt at the isthmus.The ria reamer head diameter was selected by adding 1.5 mm to the final diameter of the synream reamer head.The reamer irrigator aspirator was used for bone graft harvesting in 32 cases, intramedullary debridement and irrigation in 9 cases, and reaming for exchange nailing in 1 case.The following complications were reported as follows: 5 cases of femoral cortical perforation were observed by routine postoperative computed tomography scan, although no patient was symptomatic; of these, 4 were located at the anteromedial side of the distal metaphyseal part of the femur.The ria reamer head is sharp and the ria has less flexibility than the ordinary intramedullary reamer; which is probably why the cortical perforation occurred at this location.One of the 5 cases was a (b)(6) male (case 13).There was one case of cortical perforation at the anterior shaft (case 37) a (b)(6) male.This report is for an unknown synthes synream.This report is for one (1) unk reamers: synream.This is report 1 of 3 for complaint (b)(4).

• Brand Name: UNK - REAMERS: SYNREAM
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 13497824
• MDR Text Key: 288026980
• Report Number: 8030965-2022-00764
• Device Sequence Number: 1
• Product Code: HTO
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• 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: 01/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1