MAUDE Adverse Event Report: DEPUY MITEK LLC US UNKNOWN RIGIDFIX CROSS PIN; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number UNK RIGIDFIX

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

Patient Problems Tissue Damage (2104); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown.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.Concomitant medical products: unknown.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.[(b)(4)].

Event Description

This report is being filed after the review of the following journal article: harilainen, a., et al.(2008) "femoral cross pin (rigidfix) or absorbable screw (bioscrew) fixation vs.Tibial expansion bolt (intrafix) or absorbable screw (bioscrew) fixation in acl reconstruction with hamstring tendons.Randomized prospective study of four groups with 2-years follow-up", p15-338 (finland).This study emphasizes on finding out if there is a different clinical outcome after either cross-pin or absorbable interference screw flxation in the femur and after either expansion bolt or absorbable interference screw fixation in the tibia in anterior cruciate ligament (acl) reconstruction with hamstring tendons.The patients evaluated on course of this study: 120 patients were randomized into 4 groups in acl reconstructions with hamstring tendons: femoral rigidfix cross-pin ("rlgrdfix") and tibial expansion bolt (intrafix, n=30), rigidfix femoral and interference screw tibial fixation ("bioscrew", n=30), bioscrew femoral and intrafix tibial fixation (n=30) and bioscrew fixation into both tunnels (n=30).The evaluation methods were clinical examination, kt 2000 laxity and lido isokinetic muscle torque measurements as well as ikdc 2000 classification and knee score, tegner activity level, lysholm knee and kujala patellofemoral scores.Results: there was a higher preoperative tegner activity level in the rigidfix/intrafix group (p=0,0240) and the preoperative isokinetic flexion torque at 180 dec/sec was better in the groups with bioscrew/intrafix and bioscrew/bioscrew fixation (p=0,0316), but otherwise no differences between the study groups were observed.The article describes the following procedure: femoral cross pin (rigidfix) or absorbable screw (bioscrew) fixation vs.Tibial expansion bolt (intrafix) or absorbable screw (bioscrew) fixation in acl reconstruction with hamstring tendons the devices involved were: femoral rigidfix cross-pin ("rlgidfix") and tibial expansion bolt (intrafix, n=30), rigidfix femoral and interference screw tibial fixation ("bioscrew", n=30) complications mentioned in the article were: a revision reconstruction was performed before the 2-years follow-up in two cases after a high energy injury had caused a re-rupture (one in rigidfix/intrafix and one in bioscrew/bioscrew group).There were 4 non-traumatic failures; two in rigidfix / intrafix group, one in rigidfix/bioscrew and one in bioscrew/bioscrew groups.

• Brand Name: UNKNOWN RIGIDFIX CROSS PIN
• Type of Device: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 9295500
• MDR Text Key: 165584372
• Report Number: 1221934-2019-59455
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK RIGIDFIX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention