MAUDE Adverse Event Report: DEPUY MITEK LLC US UNK - IMPLANT; GENERAL INTERNAL ORTHOPAEDIC FIXATION SYSTEM IMPLANTATION KIT

Catalog Number UNK - IMPLANT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem 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.Patient codes: the code "no code available" was used to report the code "treatment failure." udi: unknown.The udi is unknown at this time.

Event Description

This report is being filed after the review of the following journal article: eajazi, a, et al (2013) comparison of different methods of femoral fixation anterior cruciate ligament reconstruction.Acta medica iranica, vol.51, pages 444-448 (iran).The study emphasizes on the comparison of three modes of femoral fixation, namely aperfix, rigidfix and endobutton, in anterior cruciate ligament (acl) reconstruction.120 patients were randomly assigned to three groups, each consisting of 40 patients, and each group was treated by one of the above mentioned methods of femoral fixation.All patients were examined prior to and 24 months after surgery, and they were compared for anterior tibial displacement using the lysholm score and kt-1000.The three modes of femoral fixation were not significantly different in terms of time of surgery.In the endobutton group, the lysholm score rose from 63.21±18.59 prior to acl reconstruction to 90.64±9.47 after the surgery, while it rose from 65.72±18.74 to 96.22±5.35 in the aperfix group and from 69.21±17.45 to 90.64±9.47 in the rigidfix group.Anterior tibial displacement was 3.96±1.58 mm for endobutton, 4.28±1.48 mm for rigidfix and 4.03±1.79 mm for aperfix.Aperfix was indicated to yield a better outcome in terms of instant stability and general results.The article describes the following procedure: all patients initially underwent diagnostic arthroscopy for evaluation of anterior and posterior cruciate ligaments as well as the medial and lateral menisci.Those patients whose acl rupture was confirmed on arthroscopy underwent surgery as follows: initially, an anteromedial incision was made on the proximal tibia and the gracilis and semitendinosus tendons were detached from their insertions on tibia.Subsequently, the tendons were removed to fashion the graft for acl reconstruction.A tibial canal was established; through this canal, the femoral canal was created under arthroscopy guide.Finally, the graft was passed through the canals as a single bundle.The device involved: rigidfix (depuy mitek, raynham, ma) complications mentioned in the case report were: there were 4 cases of failure in the rigidfix group.

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.H10 additional narrative: 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).Multiple attempts were done to obtain more information from the author, however, no response was received.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.Since no lot number was provided, a manufacturing record evaluation could not be conducted.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: GENERAL INTERNAL ORTHOPAEDIC FIXATION SYSTEM IMPLANTATION KIT
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10634542
• MDR Text Key: 210229342
• Report Number: 1221934-2020-02877
• 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,health professional,l
• Type of Report: Initial,Followup
• Report Date: 09/20/2020

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: No Information
• Device Catalogue Number: UNK - IMPLANT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/20/2020
• Initial Date FDA Received: 10/06/2020
• Supplement Dates Manufacturer Received: 10/20/2020
• Supplement Dates FDA Received: 10/21/2020
• Patient Sequence Number: 1