MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO ADVANCE SCREW 8X23MM; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number 231817

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Not Applicable (3189)

Event Date 11/04/2013

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the complaint device was not received and therefore an evaluation cannot be performed.A batch record 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 with two unrelated ncs 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 for this lot of devices that were released to distribution.We cannot confirm this complaint nor discern a root cause for the user to have experienced this issue.However, 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.This report is being filed from the (b)(4) as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.(b)(4).

Event Description

Device wont lock or release/gripping issue/ jaws bent or broke: the sales rep reported three different issues with three of his instruments during a shoulder procedure.He stated his ratchet handle would not ratchet making it difficult to lock and release, but the surgeon used the device anyway.The distal tip of his second device, a 23mm modular driver, kept getting stuck in the screw to the point that the screw pulled out.The surgeon used another like screw and driver in the same bone hole.The sales rep then stated the top jaw on his expressew iii with hook would not align with the bottom of the jaw and the surgeon bent it to make it align for the procedure but this caused the jaws to be completely bent by the end of the procedure.There was a ten minute delay.There were no patient consequences.The devices are coming back for evaluation.No further details were available.

• Brand Name: MILAGRO ADVANCE SCREW 8X23MM
• Type of Device: ORTHOPAEDIC BONE SCREW, 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: 8351274
• MDR Text Key: 136605867
• Report Number: 1221934-2019-56428
• Device Sequence Number: 1
• Product Code: MAI
• UDI-Device Identifier: 10886705022250
• UDI-Public: 10886705022250
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143660
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/04/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2016
• Device Catalogue Number: 231817
• Device Lot Number: 3673271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2013
• Initial Date FDA Received: 02/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1