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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US UNKNOWN RIGIDFIX CROSS PIN SOFT-TISSUE ANCHOR, BIOABSORBABLE

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DEPUY MITEK LLC US UNKNOWN RIGIDFIX CROSS PIN SOFT-TISSUE ANCHOR, BIOABSORBABLE Back to Search Results
Catalog Number UNK RIGIDFIX
Device Problem Migration or Expulsion of Device
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 product: 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: vecchini, e. , et al (2016), a complication following acl reconstruction using bioabsorbable cross-pins, acta biomed, vol. 87, pages 122-126 (italy). The study emphasizes on a (b)(6)-year-old male who had a sense of right knee instability. Physical examination demonstrated positive lachman and pivot shift tests. Three years before, the patient suffered a right knee injury due to a motorcycle accident and a complete anterior cruciate ligament (acl) rupture was later diagnosed with mri scan. The case report describes the following procedure: an acl reconstruction with autogenous gracilis and semitendinosus hamstring tendons. Two months postoperatively, the patient presented with a painful swelling on the medial side of the knee, proximal to the superomedial edge of the patella that was tender at palpation. Mri examination showed the superior femoral tunnel crossing both the lateral and medial cortex lodging the pin in the knee¿s medial soft tissue. The device involved was: 2 plla bioabsorbable pins (rigidfix cross pin system; depuy mitek, raynham, massachusetts) with a non-resorbable 8 x 30mm interference screw in the tibial tunnel. Complication mentioned in the article: the patient experienced a painful swelling of the medial side of the knee, proximal to the superomedial edge of the patella that was tender at palpation, two months postoperatively. Mri showed the superior femoral tunnel crossing both the lateral and medial cortex lodging the pin in the knee¿s medial soft tissue. Pins were removed.

 
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Brand NameUNKNOWN RIGIDFIX CROSS PIN
Type of DeviceSOFT-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 Key9226353
Report Number1221934-2019-59172
Device Sequence Number1
Product CodeHTY
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 10/18/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/23/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK RIGIDFIX
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2019
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 Unkown

Patient TREATMENT DATA
Date Received: 10/23/2019 Patient Sequence Number: 1
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