MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - IMPLANT; BONENAIL GUIDEWIRE

Catalog Number UNK - IMPLANT

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Tissue Damage (2104); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(4).Udi: the udi is unknown at this time.

Event Description

This report is being filed after the review of the following journal article: faccini, r., et al (2003) distal fixation of the osteo-tendinous graft with rigid-fix technique: results and method: tibial fixation of patellar tendon allograft with rigid fix technique: methodics and results.Vol.29, pages 203-209, (italy).The study emphasizes on a new method of distal (tibial) fixation of patellar tendon in acl reconstruction, using biodegradable pla pins.The patients evaluated on course of this study: during the period between october 2000 and january 2002, twenty patients with inveterate acl injuries, all male and aged between 18 and 38 years of age, underwent reconstruction operations of the acl with patellar graft and mitek©¿s rigid-fix fixation technique modified with both femoral and tibial fixing with absorbable pins.The article describes the following procedure: to create the tibial and femoral tunnels we use the specific centering devices and the 10 mm burs with guide wire required by the mitek© rigid-fix instrument.Having created the femoral tunnel according to the specific technique, with the mitek© femoral centering guide we measure the total length of the tunnel, from the distal end of the tibial tunnel to the upper end of the femoral tunnel, and we compare it with that of our ligament.Having positioned the four sleeves, for prior verification of the relationship between the pins and the bone bract, we check the actual direction of the pins inside the tibial and femoral tunnels using two kirschner wires, under arthroscopic control with the optics positioned in the tunnels.Once the neoligament is introduced, on the guide of the 4 sleeves we perforate each of the bracts in two points; the point of the perforating trocar penetrates 42 mm starting from the external cortex of the femur and the tibia.Once the 4 holes in the bone grafts are made, a specific introducer makes the absorbable cross pin advance, fastening the bond bract in the cancellous bone and guaranteeing a valid monocortical support.The fixation of the tibial graft is done after the femoral fixation and after adequate pre-tensioning of the graft.The devices involved were: rigidfix.Complications mentioned in the article were: we found only one case in which the pin, after 8 months, had not been absorbed even with the bone graft perfectly integrated, and had come out.This allowed us to remove it more easily under local anesthesia.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary : the complaint device is not being returned, therefore unavailable for a physical evaluation.This complaint file was opened to document complaints derived through a journal article review.The journal article review indicated depuy mitek product failure(s).No contact information was provided so no additional information follow up could be performed.It is unknown if complaints derived from this journal article were previously reported and documented in the depuy mitek complaint system at the time of occurrence as no product code/lot number information was provided to perform the search.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported problem.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

• Brand Name: UNK - IMPLANT
• Type of Device: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10612660
• MDR Text Key: 209357604
• Report Number: 1221934-2020-02820
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 09/13/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK - IMPLANT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2020
• Initial Date FDA Received: 10/01/2020
• Supplement Dates Manufacturer Received: 10/07/2020
• Supplement Dates FDA Received: 10/07/2020
• Patient Sequence Number: 1