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

Catalog Number UNK RIGIDFIX

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Discomfort (2330); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown rigidfix cross pin.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Concomitant medical products: bio-intrafix.Complainant part is not expected to be returned for manufacturer review/investigation.(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.

Event Description

This report is being filed after the review of the following journal article: seung-suk seo et al, 2013, "results of anterior cruciate ligament reconstruction using second look arthroscopic examination: focus on graft material and age", the journal of the korean orthopaedic association, volume 48 number 4, page no: 273-280, south korea.The study emphasizes on comparison of clinical, radiological, and second-look arthroscopic results of arthroscopic anterior cruciate ligament reconstruction according to the type and age of graft tendon.The patients evaluated on course of this study: 57 patients underwent arthroscopic acl reconstruction and second look arthroscopic examination from january 2006 to december 2009.They divided patients according to graft materials into the autogenic hamstring tendon group (group 1) and the allogenic tibialis tendon group (group 2), and according to age into three groups (a, b, and c), and respectively, below 29 years of young age group, 30-49 years of intermediate age group, and over 50 years of old age group.The mean age at first operation for arthroscopy was 32 years old.The mean age at follow-up for second-look arthroscopy was 34 years old.Fifty-four patients were male and three patients were female.Of these, 29 males and one female were in group 1 and 25 males and 2 females were in group 2.There were 14 cases in 1a, 11 cases in 1b, 5 cases in 1c, 10 cases in 2a, 12 cases in 2b, and 5 cases in 2c.The inclusion criteria were accompanying (meniscal injuries), traffic accidents, osteochondral lesions.The article describes the following procedure: anterior cruciate ligament reconstruction by using autogenous hamstring tendon or allogeneic tibialis tendon.Mean follow-up period was 21.8 months.The devices involved were: bioabsorbable rigid fix® cross pin system was used to fix graft tendon on the thigh while depuy mitek intrafix system was used to fix graft tendon on the tibial side.In addition, cortical screw was used in the anterior cortical bone of the proximal tibia to perform a landing knot.Non-absorbable sutures were used to prepare allogeneic tendons by doubling the anterior tendon.Complications mentioned in the article were: two cases of soft tissue stimulation (discomfort, foreign body sensation) were reported due to the protrusion of the cross pin head after the operation.A copy of the literature article is attached to this medwatch.

Manufacturer Narrative

Depuy is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy or its employees that the report constitutes an admission that the device, depuy , or its employees caused or contributed to the potential event described in this report.H6: device code correction.

• 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
• MDR Report Key: 8812022
• MDR Text Key: 151739794
• Report Number: 1221934-2019-57726
• Device Sequence Number: 1
• Product Code: MAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 07/04/2019

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
• Initial Date Manufacturer Received: 07/04/2019
• Initial Date FDA Received: 07/22/2019
• Supplement Dates Manufacturer Received: 07/04/2019
• Supplement Dates FDA Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention