MAUDE Adverse Event Report: DEPUY MITEK INTRAFIX ® PEEK TAPERED SCREW 6-8MM X 30MM; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Catalog Number	254652
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	05/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4) - incomplete.The expiration date is currently unavailable.
Event or Problem Description
It was reported by the sales rep that the patient experienced a fractured tibial plateau two months after an acl procedure due to the intrafix tibial sheath trial/t-handle migrating into the joint surface.The case was completed without any issues prior to the incident.The customer is refusing to send the device back.The sales rep provided additional information via phone on 12-11-2017 that the surgery date was (b)(6) 2017.The sales rep also stated that it was a intrafix peek taper screw, 6-8 mm x 30 mm that had migrated up the tibial plateau in the patient.The screw was not removed but it was brought back down with another screw and suture.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device was retained by the customer and will not be returned therefore, device is not available for a physical evaluation.This complaint is not confirmed.It was reported that two months after an acl procedure the implanted intrafix peek taper screw migrated into the joint surface.No further information regarding the procedure, patient condition or the device used has been provided to determine a root cause for this failure.The dhr review indicated that this batch of devices were processed without incident, therefore, there is no evidence of manufacturing anomalies on the records reviewed.Further, a review of the depuy synthes mitek complaints system revealed no complaints of any type for this lot of devices that were released to distribution.Based on the information available this complaint will be accounted for and monitored via post market surveillance activities.However, if additional information is made available, the investigation will be updated as applicable.At this point in time, no corrective action is required, and no further action is warranted.Depuy 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: (b)(4).

• Brand Name: INTRAFIX ® PEEK TAPERED SCREW 6-8MM X 30MM
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7137042
• Report Number: 1221934-2017-50087
• Device Sequence Number: 13720376
• Product Code: MAI
• UDI-Device Identifier: 10886705022380
• UDI-Public: 10886705022380
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2018
• Report Date (Section F): 05/18/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 254652
• Device Lot Number: 3919673
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2017
• Initial Date Received by Manufacturer: 05/18/2017
• Supplement Date Received by Manufacturer: 04/09/2018
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention