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

Catalog Number UNK BIO-INTRAFIX

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Pain (1994)

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.

• Brand Name: UNKNOWN BIOINTRAFIX ANCHOR
• Type of Device: MITEK 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 Key: 5752038
• MDR Text Key: 48258480
• Report Number: 1221934-2016-10258
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• 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 Received: 06/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK BIO-INTRAFIX
• Device Lot Number: UNKNOWN
• 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 Manufacturer: 05/31/2016
• Date Manufacturer Received: 05/31/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR