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 Problem 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 products: 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: matteo, d., et al.(2008) "revision anterior cruciate ligament reconstruction", the american journal of sports medicine, vol.36, no.10, pages 1896-1902 (italy).The study emphasizes on evaluating the results of revision acl reconstruction at a midterm follow-up.The patients evaluated on course of this study: a total of 66 revisions of anterior cruciate ligament reconstructions were carried out from september 2000 to september 2004.Patients with concomitant instability and those with alterations in the weightbearing axis of the lower limbs were not included.Sixty patients were followed from 24 to 72 months: 50 clinically and 10 by a phone interview.Six patients were lost to follow-up due to changes of address.There were 3 different categories of reconstruction failure: 52% surgical (including 6 synthetic ligament failures), 35% traumatic, and 3% biological.Our criteria for defining a failure ln each category were determined by history, imaging, and arthroscopic findings.Particularly, we classified a failure as surgical when, according to imaging and arthroscopy, the graft appeared to be positioned incorrectly; as traumatic when the described trauma could cause the graft lesion even though imaging and arthroscopy showed a correct graft position; and biological when the patient did not experience a trauma, and the graft appeared well positioned on imaging and arthroscopy.Lysholm scores were 57% excellent (95-100 points), 13% good (84-94 points), 22% fair (63-83 points), and 8% poor (<64 points).A total of 68% of patients had negative lachman tests, 20% had positive tests with a hard end point, 10% had positive results, and 2% had very positive results.Stabilometric evaluation with the kt-1000 arthrometer at the maximum load showed that 56% of patients had <3 mm side-to-side difference, 34% had between 3 and 5 mm, and 10% had 6 to 10 mm.The international knee documentation committee scores were 36% excellent (class a), 46% good (class b), and 18% fair (class c).The percentage of patients who resumed sport at the same level was 78%, compared with 58% after their primary reconstruction.The results of these anterior cruciate ligament reconstruction revision surgeries are close to those achieved by other series of primary reconstructions with a little less satisfactory results.We attribute the high success rate to the strict application of the same technique and the confinement of revision to motivated patients.It should be noted, however, that follow-up is only at the midterm stage (mean, 41.9 months).The article describes the following procedure: anterior cruciate ligament reconstruction surgery.The devices involved were: fixation was with bioabsorbable screw and titanium screw, interference screws in patellar tendon revision acl reconstructions.In doubled semitendinous and gracilis revision acl reconstructions, fixation was achieved with femoral bioabsorbable cross-pins (rigidfix cross pin system, mitek, raynham, mass) and a bioabsorbable interference screw at the tibia.Complications mentioned in the article were: the patellar tendon was used in 27 cases (in 13 cases it was the contralateral one for a high-demand sports activity or the patellar chondral status) and an achilles allograft in 2 cases.Meniscal lesions and cartilage lesions.

• 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: 9165958
• MDR Text Key: 172930357
• Report Number: 1221934-2019-58816
• 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: 10/03/2019

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/08/2019
• 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