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

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

This report is being filed after the review of the following journal article: giotikas d., et al (2019) results of the induced membrane technique in the management of traumatic bone loss in the lower limb: a cohort study, orthop trauma volume 33, pages 131¿136 (united kingdom).This retrospective cohort study aims to present the methods and results in the management of open lower limb fractures with aggressive debridement and the use of the reamer/irrigator/aspirator (ria, de puy synthes) for bone graft harvesting and the addition of antibiotic-loaded absorbable calcium sulfate pellets in both, the pmma spacer and bone graft.Between november 2013 and december 2014, thirteen patients (11 males and 2 females) with mean age in years 37.6 (range 23¿69, 14.7) with 14 open fractures were identified to have been treated with the masquelet technique.All patients were older than 16 years with acute open fractures of the tibia or femur.During the second stage, bone graft was harvested from the femoral canal using the ria with the standard technique, as described by the manufacturer and in the literature.The mean follow-up was 17 months.The following complications were reported as follows: (death) one patient committed suicide at approximately 6 months postoperatively.In 1 case, significant (2 l) and rapid blood loss occurred shortly after initiation of reaming with the ria.This report is for an unknown synthes reamer/irrigator/aspirator (ria).It captures the reported event of in 1 case, significant (2 l) and rapid blood loss occurred shortly after initiation of reaming with the ria.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

This report is for an unknown ria/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.

• Brand Name: UNK - RIA
• Type of Device: REAMER
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wrights lane east; west chester, PA 19380 ; 6103142063
• MDR Report Key: 13483004
• MDR Text Key: 287910670
• Report Number: 8030965-2022-00757
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 01/10/2022
• Initial Date FDA Received: 02/08/2022
• 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