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 Unspecified Infection (1930); 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.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: ahn, jh., et al.(2008), "comparison of revision surgery with primary anterior cruciate ligament reconstruction and outcome of revision surgery between different graft materials", the american journal of sports medicine, vol.36, no.10, pages 1889-1895 (korea).The study emphasizes the clinical and stability results between primary and revision acl reconstruction and the results of revision surgery between different graft materials.The patients evaluated on course of this study: this retrospective study included 55 patients (56 operations) who were available for follow-up among 59 operations between january 1997 and october 2005.Fifty-two primary acl reconstructions (92.9%) had been done by other surgeons with use of 15 achilles allografts, 14 bone-patellar tendon-bone (bptb) allografts, 9 bptb autografts, 5 artificial ligaments, 5 double-looped semitendinosus and gracilis autografts, and 4 achilles autografts.The 4 patients had undergone reconstruction with bptb autografts.Among 4 patients, 3 patients were advised because of traumatic rerupture, and 1 patient was revised because of infection.A double-looped semitendinosus and gracilis autograft were used because it has better results in terms of ligamentization of second-look arthroscopies.Bptb allograft was used in the case of athletes because of rapid bone-to-bone healing and achilles allograft in the case of tunnel widening because of the additional bone graft with remnant bone.Twenty-one (37.5%) knees had revision reconstruction with previously unharvested ipsilateral double-looped semitendinosus and gracilis autografts.Twenty (35.7%) were bptb allografts, and 15 (26.8%) were achilles allografts.For the primary acl reconstruction, we evaluated a series of 117 consecutive patients who underwent arthroscopic acl reconstruction using double-looped semitendinosus and gracilis autografts fixed width 2 bioabsorbable cross-pins on the femoral side from september 2001 to november 2002.The article describes the following procedure: all patients were examined under general anesthesia (lachman test, pivot-shift test, varus and valgus stress test, posterolateral instability test), after which routine (diagnostic arthroscopy was performed.Meniscal injury and articular cartilage lesion were evaluated and, if necessary, meniscectomy or meniscal repair and treatment for a cartilage lesion (chondroplasty or microfracture) were performed.The devices involved were: rigidfix cross-pins (rigldfix system, mitek, johnson & johnson, (b)(4)) with temporary insertion of wire, the hamstring autograft was inserted.Complications mentioned in the article were: 3 patients were revised because of traumatic rerupture, and 1 patient was revised because of infection.

• 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: 9134445
• MDR Text Key: 166155603
• Report Number: 1221934-2019-58663
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 09/16/2019

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: 09/16/2019
• Initial Date FDA Received: 09/30/2019
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention