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 Unspecified Infection (1930); Loss of Range of Motion (2032); 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 is report 2 of 2 for the same event.This report is being filed after the review of the following journal article: choi, n.H., et al.(2008) "anterior cruciate ligament reconstructions with hamstring tendons using bioabsorbable double cross-pin femoral fixation", p15-499 (korea).This study emphasizes on reporting clinical outcomes after anterior cruciate ligament (acl) reconstruction with hamstring tendon autograft fixed with bioabsorbable double cross-pins.The patients evaluated on course of this study: 46 patients who were available for at least 24 months follow-up were enrolled in this study.The hamstring graft was fixed with rigidfix (mitek, norwood, ma) at femoral side and inti-afix (mitek) at tibial side.Preoperative and postoperative laxity evaluations were performed using lachman test, pivot-shift test, instramented laxity testing using kt-iooo arthrometer and intemational knee documentation committee (ucdc) knee examination form.Functional evaluations were performed using the tegner activity level and the lysholm knee scoring scale.The average follow-up was 36.2 months.Preoperatively, the lachman tests were graded i+ in 23 patients and 2+ in 23.The pivot-shift tests were i+ in 27 patients and 2+ in 19.At last follow-up, the lachman tests were graded 0 in 24 patients and l-i- in 22.The pivot-shift tests were 0 in 32 patients and 1+ in 14 (p<0.001).Preoperatively, the mean tegner activity level was 3.2 and the mean lysholm score was 62.6.At last follow-up, the mean tegner activity level was 5.7 and the mean lysholm score was 97.3 (p<0.001).Preoperative mean laxity on kt-iooo arthrometer examination was 5.4 mm and postoperative mean laxity was 1.5 mm (p<0.001).Preoperatively, 14 patients were graded as nearly normal, 26 were abnormal, and 6 were severely abnormal according to ucdc knee examination form.Postoperatively, 27 patients were graded as normal, 16 were nearly normal, and 3 were abnormal (p<0.001).There were two complications associated with surgery.One patient required manipulation under anesthesia because of postoperative stiffness.Two patients had superficial infections.The article describes the following procedure: anterior cruciate ligament reconstructions with hamstring tendons.The devices involved were: the hamstring graft was fixed with rigidfix (mitek, norwood, ma) at femoral side and intrafix (mitek) at tibial side.Complications mentioned in the article were: one patient required manipulation under anesthesia because of postoperative stiffness.Two patients had superficial infections.

• 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: 9295435
• MDR Text Key: 184305649
• Report Number: 1221934-2019-59438
• 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: 11/05/2019

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 RIGIDFIX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/08/2019
• 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