MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - IMPLANTS - RIGIDFIX; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Catalog Number UNK - IMPLANTS - RIGIDFIX

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

Patient Problem Tissue Damage (2104)

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.

Event Description

This report is being filed after the review of the following journal article: seo, ss., et al.(2011) "acl reconstruction with autologous hamstring tendon: comparison of short term clinical results between rigid-fix and pinn-acl cross pin", knee surgery & related research, vol.23, no.4, pages 208-212 (korea).This study emphasizes on comparing the short term clinical results of anterior cruciate ligament (acl) reconstruction with autologous hamstring tendon between rigid-fix and pinn-acl cross pin for femoral side fixation.The patients evaluated on course of this study: 127 patients who underwent arthroscopic acl reconstruction using autologous hamstring tendon and had been followed-up for over than one year were enrolled for the present study.Rigid-fix was used in 71 cases (group 1), and pinn-acl cross pin was used in 56 cases (group 2).Clinical and radiological results, operation time, and perioperative complications were compared amongst the two groups.The international knee documentation committee subjective score and lysholm score were 94 and 95 in group 1 and 87 and 91 in group 2, with no statistical difference (p=0.892, p=0.833), respectively.However, significant difference was observed in one-leg hop test between the two groups (p=0,032).Five cases in group 1 and 40 cases in group 2 were found to be associated with perioperative complications with statistical difference (p<0.0001).The article describes the following procedure: anterior cruciate ligament (acl) reconstruction with autologous hamstring tendon.The devices involved were: rigidfix (mitek, norwood, ma, usa), intrafix (mitek, norwood, ma, usa) and a cancellous suspension device, pinn-acl cross pin.Complications mentioned in the article were: regarding the complications, the incidence of cross pin-femoral tunnel mismatch was higher in group ii, with 4 cases in group i and 36 cases in group ii (p=0.017).Soft tissue irritation from cross pin head prominence was observed in 1 case in group i and 4 cases in group ii, which further improved 2 months later in all the cases.

• Brand Name: UNK - IMPLANTS - RIGIDFIX
• 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: 9186654
• MDR Text Key: 173020048
• Report Number: 1221934-2019-58939
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 10/09/2019

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
• Device Catalogue Number: UNK - IMPLANTS - RIGIDFIX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2019
• Initial Date FDA Received: 10/14/2019
• 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