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 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 tibial guide.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 is report 1 of 2 for the same event.This report is being filed after the review of the following journal article: ahn, jh., et al.(2011) ¿outcomes and second-look arthroscopic evaluation after double-bundle anterior cruciate ligament reconstruction with use of a single tibial tunnel¿, the journal of bone & joint surgery, vol.93-a, no.20, pages 1865-1872 (korea).The study emphasizes the correlation between graft appearance and clinical outcome after double-bundle anterior eructate ligament (acl) reconstruction.The graft appearance was assessed with use of second-look arthroscopy and was correlated with the clinical outcome.The patients evaluated on course of this study: a double-bundle acl reconstruction with use of the one tibial tunnel technique was performed at the institution on 114 knees between july 2005 and july 2007.Thirty-seven knees that underwent second-look arthroscopy after double-bundle agl reconstruction and sixty-two knees that underwent double-bundle acl reconstruction without subsequent second-look arthroscopy were included in this retrospective study.The ninety-nine patients enrolled were followed for thirty-five months (range, twenty-four to fifty-eight months), and the mean duration from acl reconstruction to second-look arthroscopy was twenty-five months (range, twelve to thirty-six months).Graft thickness, apparent graft tension, and synovial coverage were graded during second look arthroscopy: correlations were sought between graft appearance and lysholm knee scores, international knee documentation committee (ikdc) grades, anterior laxity, and pivot-shift test results.Postoperatively, ninety-four (94.9%) of the ninety-nine knees had an ikdc rating of b or higher, mean anterior laxity was 1:29 mm (range, 0 to 6 mm), and ninety-two knees (92.9%) had a negative pivot-shift result.With regard to graft thickness and tension, anteromedial bundles were graded as a in twenty-eight (75:7%) of the thirty-seven second-look knees and as b in nine knees (24.3%).Posterolateral bundles were graded as a in twenty-five knees (67.6%), b in six knees (16.2%), and c in six knees (16.2%).With regard to synovial coverage, anteromedial bundles were graded as c in only two knees (5.4%) and posterolateral bundles were graded as g in six knees (16:2%).No correlation was found between graft appearance and clinical outcome.The article describes the following procedure: all surgical procedures were performed by a single senior surgeon (j.H.A.) using a hamstring autograft.The devices involved were: n acl tibial guide (mitek, norderstedt, germany) and the sleeves of a bioabsorbable pin (rigidfix; ethicon, mitek division, norderstedt, germany).Complications mentioned in the article were: one patient had a multiple ligament injury, two patients had a prior contralateral acl reconstruction, two had simultaneous medial collateral ligament reconstruction.

• 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: 9140805
• MDR Text Key: 167552494
• Report Number: 1221934-2019-58724
• 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: 09/23/2019

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: 09/23/2019
• Initial Date FDA Received: 10/01/2019
• 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