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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK UNKNOWN BIOINTRAFIX ANCHOR MITEK ACL IMPLANTS

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DEPUY MITEK UNKNOWN BIOINTRAFIX ANCHOR MITEK ACL IMPLANTS Back to Search Results
Catalog Number UNK BIO-INTRAFIX
Device Problem Migration or Expulsion of Device
Event Type  Injury  
Manufacturer Narrative

Mitek medical safety department discovered this published white paper detailing a historical event in which some mitek devices were implicated. It cannot be confirmed that this issue had been previously reported to mitek, so an adverse event report is being filed to document the experience described in the article. At this point in time, no further action is warranted. However, this file will remains receptive to any potential forthcoming information received that is pertinent and germane to this issue. 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. Udi: not available. The catalog number is not available.

 
Event Description

The following issue was discovered via a published journal article by the mitek medical safety personnel. Authors: kathryn metcalf,* ba, jia-wei kevin ko,* md, samantha quilici,* pa, penelope barnes,* mbbs, phd, and dennis c. Crawford,* md, phd. Reference: differentiating occult propionibacterium acnes infection from aseptic "biologic" interference screw hydrolysis after anterior cruciate ligament reconstruction (b)(6). A (b)(6) woman sustained a right knee acl tear while dancing. The patient underwent arthroscopic acl reconstruction using the bioabsorbable bio intrafix system. Three years post surgery, the patient returned after several months of increased pain at the medial tibia. Examination revealed tenderness at the medical proximal tibia hardware fixation site, but no fever, effusion, or systemic signs of infection. Radiographs suggested a loose interference screw and elective removal of the tibial interference screw was recommended and scheduled. A fragmented interference screw, with 25% of the original unabsorbed volume was removed.

 
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Brand NameUNKNOWN BIOINTRAFIX ANCHOR
Type of DeviceMITEK ACL IMPLANTS
Manufacturer (Section D)
DEPUY MITEK
325 paramount drive
raynham MA 02767
Manufacturer Contact
jason busch
325 paramount drive
raynham , MA 02767
5088808210
MDR Report Key5752038
Report Number1221934-2016-10258
Device Sequence Number1
Product CodeHTY
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 05/31/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/27/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNK BIO-INTRAFIX
Device LOT NumberUNKNOWN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Date Report TO Manufacturer05/31/2016
Date Manufacturer Received05/31/2016
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 TREATMENT DATA
Date Received: 06/27/2016 Patient Sequence Number: 1
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