MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - GUIDE; BONENAIL GUIDEWIRE

Catalog Number UNK - GUIDE

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

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).Patient code: "no code available" used to report surgical intervention.Udi: the udi is unknown at this time.

Event Description

This report is being filed after the review of the following journal article: snoj, z, et al (2017) the effect of anterior cruciate ligament reconstruction technique on graft signal intensity at mid-term follow-up.Musculoskeletal imaging, vol.15(1), pages 1-7 (slovenia).The study emphasizes on anterior cruciate ligament reconstruction (acl-r) technique affecting graft positioning.However, how acl graft positioning affects graft signal intensity (gsi) is yet unknown.The aim of our study was to find out if acl-r technique affects gsi at mid-term follow-up.The patients evaluated on course of this study: a total of 50 patients were included in the study.They underwent 3.0 t mri of the knee 4-7 years after acl-r.Patients were divided into two groups according to acl-r technique (transtibial technique with rigidfix fixation group 1 and anteromedial portal technique with endobutton fixation group 2).Gsi, graft failure, graft impingement and graft position were assessed.Gsi characteristics were evaluated on proton density turbo spin echo fat saturation images.Graft was divided into two portions, intraarticular portion (iap) and intraosseous portion (iop).Intraosseous portion was further divided into two parts femoral (fiop) and tibial (tiop).The article describes the following procedure: at acl-r, arthroscopic examination was performed to confirm acl rupture.In all patients, single-bundle, quadruple stranded stgr auto-grafts were used.In both groups, tibial tunnel was drilled at a sagittal angle of 60° to the tibial plateau with the use of tibial drill guide (mitek, johnson& johnson, norwood, ma,usa).The graft was fixed by using milagro interference screw (depuy mitek, raynham, ma, usa).In the tt group, the knee was positioned in 90° flexion and cannulated end-cutting head design reamer (mitek, johnson & johnson, norwood, ma, usa) was introduced transtibially drilling the femoral tunnel to the depth of 25 to 30 mm.In the femoral tunnel, the graft was fixed by using rigidfix (mitek, johnson & johnson, norwood, ma, usa).In the am group, the knee was positioned in 120° flexion and cannulated end-cutting head design reamer (mitek, johnson& johnson, norwood, ma, usa) was passed through the am portal drilling the femoral tunnel to the depth of 25 to 30 mm.In the femoral tunnel, the graft was fixed by using endobutton (smith & nephew endoscopy, andover, ma, usa).The devices involved were: tibial drill guide, milagro interference screw.Complications mentioned in the article were: graft failure, six (12.0%) patients had ruptured acl graft.Patients from group 1 tended to have lower graft failure rates than patients from group 2 one (4.0%) patient vs.Five (20.0%) patients; p = 0.08.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device is not being returned, it was discarded, therefore unavailable for a physical evaluation.This complaint file was opened to document complaints derived through a journal article review.The journal article review indicated depuy mitek product failure(s).Multiple attempts were done to obtain more information from the author, however, no response was received.It is unknown if complaints derived from this journal article were previously reported and documented in the depuy mitek complaint system at the time of occurrence as no product code/lot number information was provided to perform the search.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported problem.Since no lot number was provided, a manufacturing record evaluation could not be conducted.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: UNK - GUIDE
• Type of Device: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10556947
• MDR Text Key: 210221591
• Report Number: 1221934-2020-02670
• Device Sequence Number: 1
• Product Code: NBH
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - GUIDE
• Device Lot Number: UNKNON
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 09/18/2020
• Supplement Dates Manufacturer Received: 10/19/2020
• Supplement Dates FDA Received: 10/19/2020
• Patient Sequence Number: 1