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

Catalog Number UNK RIGIDFIX

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); 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 product: 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 report is being filed after the review of the following journal article: vecchini, e., et al (2016), a complication following acl reconstruction using bioabsorbable cross-pins, acta biomed, vol.87, pages 122-126 (italy).The study emphasizes on a (b)(6)-year-old male who had a sense of right knee instability.Physical examination demonstrated positive lachman and pivot shift tests.Three years before, the patient suffered a right knee injury due to a motorcycle accident and a complete anterior cruciate ligament (acl) rupture was later diagnosed with mri scan.The case report describes the following procedure: an acl reconstruction with autogenous gracilis and semitendinosus hamstring tendons.Two months postoperatively, the patient presented with a painful swelling on the medial side of the knee, proximal to the superomedial edge of the patella that was tender at palpation.Mri examination showed the superior femoral tunnel crossing both the lateral and medial cortex lodging the pin in the knee¿s medial soft tissue.The device involved was: 2 plla bioabsorbable pins (rigidfix cross pin system; depuy mitek, raynham, massachusetts) with a non-resorbable 8 x 30mm interference screw in the tibial tunnel.Complication mentioned in the article: the patient experienced a painful swelling of the medial side of the knee, proximal to the superomedial edge of the patella that was tender at palpation, two months postoperatively.Mri showed the superior femoral tunnel crossing both the lateral and medial cortex lodging the pin in the knee¿s medial soft tissue.Pins were removed.

• 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: 9226353
• MDR Text Key: 176593143
• Report Number: 1221934-2019-59172
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 10/18/2019
• 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
• Patient Age: 33 YR