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 Hematoma (1884); 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.Concomitant medical products: unknown.(b)(4).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: bataga, t., et al.(2008) "reconstruction of the anterior cruciate ligament with bioresorbabile fixation: comparison of patellar bone-tendon-bone and hamstring tendon graft methods - a five years clinical study", p15-226 (romania).This study emphasizes on the high number of patients with femoropatellar complaints following acl reconstruction with bone-tendon-bone (b-t-b) autograft led us to use and subsequently evaluate hamstring tendon grafts fixed with the rigidfix system.In this study we present the evaluation of short-term results.The patients evaluated on course of this study: they evaluated 265 patients (151 male and 114 female) at an average follow-up of 18 months.The average age of the group was 29.7 years (range, 16 to 59 years).In 146 patients they treated the right knee and in 119 patients the left knee.Fifty-five patients in this group also had an associated injury to the soft knee tissues.For reconstruction, a semitendinosus-gracilis quadruple tendon graft was use in 165 patient and btb in 100.The operation was carried out with tourniquet application to the extremity in a flexed position.The tendons of die semitendinosus and gracilis was harvested through an oblique incision and, in some cases, when its width and length was not sufficient for graft construction, the gracilis muscle tendon was harvested too.The graft, at least 75 mm by 8 mm in size, was prepared on a graft board.After having drilled the bolh tunnels, the femoral rigidfix reamer was inserted in a routine manner and protective sleeves for rigidfix cross pins were introduced.With the extremity in semiflexion, the inserted graft was fixed to the cortical bone by absorbable cross pins on the femur and absorbable interference screws on the tibia.The postoperative treatment involved procedures as in the b-t-b technique.The group was evaluated by the lysholm score system, with an average of 84.3 scores achieved.The men showed better outcomes than women, i.E, 85.7 and 81.4, respectively.The scores in the patients with a combined tendon (semitendinosus, 83.2 vs.Semitendinosus-gracilis, 84.2), nor did they greatly differ between the patients with injury to acl alone and those with acl and associated soft tissue injuries (acl, 83.9 vs.Acl+ associated injury, 85.5).Most of the patients (94 %) were satisfied with the outcome of treatment.The complications involved thrombosis of the operated lower extremity in three patients and repeat surgery for hematoma in two patients.Knee instability was found in five patients.One graft failed to restructure and incorporate, in two knee tunnels were incorrectly centered and two grafts ruptured due to trauma.Three of these patients underwent repeat surgery.The article describes the following procedure: reconstruction of the anterior cruciate ligament with bioresorbable fixation.The devices involved were: after having drilled the bolh tunnels, the femoral rigidfix reamer was inserted in a routine manner and protective sleeves for rigidfix cross pins were introduced complications mentioned in the article were: the complications involved thrombosis of the operated lower extremity in three patients and repeat surgery for hematoma in two patients.Knee instability was found in five patients.One graft failed to restructure and incorporate, in two knee tunnels were incorrectly centered and two grafts ruptured due to trauma.Three of these patients underwent repeat surgery.

• 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: 9295511
• MDR Text Key: 185529787
• Report Number: 1221934-2019-59451
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: RO
• 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: 11/06/2019

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: 11/06/2019
• 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