MAUDE Adverse Event Report: DEPUY MITEK LLC US INTRAFIX TIBIALSHEATH 30MM *EA; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number 254601

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Investigation summary: the complaint indicates that the device was discarded and will not be available for evaluation.A photograph of the patient¿s knee was provided, and it shows the proximal end of the screw from the intrafix screw & sheath system is protruding through the skin.It has backed out of the bone hole.No additional information was provided that would help us to determine the cause of his failure.This complaint can be confirmed.A manufacturing record evaluation was performed on 4-16-2019 for the part-lot number combination, and no non-conformances were identified.We cannot discern a root cause for the reported failure mode.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes 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.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.A non-conformance search was performed and no non-conformances were identified for the part/lot number combination.(b)(4).

Event Description

This is report 1 of 2 for the same event.It was reported by the sales rep via phone that on (b)(6) 2018, the patient underwent the first acl reconstruction procedure with the intrafix sheath and screw.After approximately five months post-opt, the patient noticed redness and a pin-hole opening around the procedure site.The sales rep stated that the screw was visibility pushing against the skin.The patient went back for a revision procedure on (b)(6) 2019 to have the sheath and the screw removed.The sales rep stated that while removing the implants from the patient, there was no infection noticed.The sales rep stated that no replacement implants were inserted into the patient during this procedure.The implants were discarded by the customer.There was patient involvement reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Type of Device: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 8577939
• MDR Text Key: 143969821
• Report Number: 1221934-2019-56987
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705013074
• UDI-Public: 10886705013074
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 254601
• Device Lot Number: L973565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2019
• Initial Date FDA Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: No
• 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