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 Problems Adhesion(s) (1695); Not Applicable (3189)

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 bio-intrafix.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 is report 2 of 2 for the same event.This report is being filed after the review of the following journal article: samir abdul razik ibrahim et al, 2013 ¿surgical management of traumatic knee dislocation with posterolateral corner injury¿, arthroscopy: the journal of arthroscopic and related surgery, vol 29, no.4: pp 733-741 (kuwait).The purpose of the study is to evaluate the results of our method of surgical treatment of traumatic knee dislocation with injury to the posterolateral corner by use of a standardized protocol.Twenty-five consecutive patients presented with a grossly dislocated or reduced knee.Five of these patients were not included in this series.The remaining 20 patients were treated by primary arthroscopic reconstruction.The anterior cruciate ligament (acl) was reconstructed using gracilis tendon reinforced with artificial ligament (ligament augmentation and reconstruction system [lars] ligament); the posterior cruciate ligament (pcl) was reconstructed with semitendinosus tendon and reinforced with lars ligament; and the posterolateral corner was treated using the gracilis and semitendinosus tendons from the uninjured knee.Twenty patients returned for subjective and objective evaluation at a minimum of 24 months after surgery.Early mobilization through continuous and active exercise was started on the fourth day postoperatively.The devices involved were: rigidfix cross-pin fixation (depuy mitek, (b)(4)), bio-intrafix screws (depuy mitek).At a mean follow-up of 44 months, the mean lysholm score was 90 points, the mean score on the survey of daily activities was 90 points, and the sports activities score on the knee outcome survey averaged 80 points.By the rating of meyers et al.The results were excellent in 6 patients, good in 10 patients, fair in 3 patients, and poor in one patient.The final international knee documentation committee (ikdc) rating was not normal in any knee.The mean loss of extension was 2° (range, 0° to 3°) and loss of flexion was 12° (range, 10° to 15°).Complications mentioned in the study: postoperative stiffness occurred in 4 patients, all of whom were treated with manipulation under anesthesia (correcting loss of flexion) and arthroscopic release of adhesions.All patients improved their range of motion except one patient who had loss of flexion of 10°.One patient sustained a hematoma in the uninjured limb, which required incision and drainage.The symptoms were resolved in this patient.From the review of the article,by using the described method of arthroscopically assisted reconstruction of the cruciate ligaments and the posterolateral corner, 80% of the patients had good subjective results and functional stability, and according to the ikdc scale, 45% of knees were nearly normal, 45% were abnormal, and 10% were severely abnormal.No patient's rating returned to normal.

• 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: 9167514
• MDR Text Key: 170433134
• Report Number: 1221934-2019-58849
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: KU
• 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: 10/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• 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
• Date Manufacturer Received: 10/06/2019
• 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): Hospitalization; Required Intervention