MAUDE Adverse Event Report: DEPUY MITEK MITEK RIGIDFIX PLA 3.3MM FEMORAL CROSS PIN KIT; ACL IMPLANTS

Catalog Number 210133

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Surgical procedure, repeated (2042)

Event Type  Injury  

Event Description

This complaint file is being used to document the fourth of four revision arthroscopic surgeries performed on the same patient, following a revision surgery documented in medwatch 1221934-2014-00064, although specific dates and locations are unknown.During the sales rep¿s call to us on (b)(4) 2014, he stated that he received a call from an attorney on (b)(6) 2014 inquiring as to how long our rigidfix pins take to be fully absorbed by the body.During the rep¿s call to the physician¿s assistant on or after (b)(6) 2014, the pa informed our rep that four additional surgical procedures had occurred as a result of the patient¿s reported pain.The physician assistant reported these four additional procedures that were performed at various facilities by different surgeons were as a result of additional opinions that the patient sought because of her reported pain, however, the rep was told that no further loose bodies were discovered.See associated medwatch #s 1221934-2014-00064, 1221934-2014-00065, 1221934-2014-00066, and 1221934-2014-00067.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek.Depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.

Manufacturer Narrative

The complaint device has not been returned.No further information regarding the patient or the event was available to determine the root cause of the reported failure.A batch record review has been conducted and the results indicate that this batch of product was processed without any incident related to the complaint and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed one dissimilar complaint with no patient consequences for this lot of devices that were released to distribution.From the complaint history, it seems that this failure is an anomaly and an isolated incident.At this point in time, no further action is warranted.However, should any new information be provided in future, this file will be re-opened and a thorough investigation will be performed.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.

Event Description

This complaint file is being used to document the fourth of four revision arthroscopic surgeries performed on the same patient, following a revision surgery documented in medwatch 1221934-2014-00064, although specific dates and locations are unknown.During this complaint file is being used to document the fourth of four revision arthroscopic surgeries performed on the same patient, following a revision surgery documented in medwatch 1221934-2014-00064, although specific dates and locations are unknown.During the sales rep¿s call to us on february 4, 2014, he stated that he received a call from an attorney on january 30, 2014 inquiring as to how long our rigidfix pins take to be fully absorbed by the body.During the rep¿s call to the physician¿s assistant on or after january 30, 2014, the pa informed our rep that four additional surgical procedures had occurred as a result of the patient¿s reported pain.The physician assistant reported these four additional procedures that were performed at various facilities by different surgeons were as a result of additional opinions that the patient sought because of her reported pain, however the rep was told that no further loose bodies were discovered.See associated medwatch's 1221934-2014-00064, 1221934-2014-00065, 1221934-2014-00066, and 1221934-2014-00067.

• Brand Name: MITEK RIGIDFIX PLA 3.3MM FEMORAL CROSS PIN KIT
• Type of Device: ACL IMPLANTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: david primmerman ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 3629764
• MDR Text Key: 17386929
• Report Number: 1221934-2014-00068
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2014
• Device Catalogue Number: 210133
• Device Lot Number: 3492971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/30/2014
• Date Manufacturer Received: 01/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2011
• 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