MAUDE Adverse Event Report: DEPUY MITEK LLC US ABSOLUTE INTSCR 9X23MM *EA; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	254505
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	11/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The complaint device was received.Upon visual observation the threads on the distal tip of the screw due appear to be flattened confirming the failure mode.From the event description, the surgeon had difficulty placing the screw and observed that the end of the screw thread was flattened on one side.One possible conclusion is this failure occurred during insertion and possibly due to hard bone quality of the patient.We cannot discern a root cause outside this possibility at this point.A review into the depuy synthes mitek complaints system revealed no other complaints of any type for this lot of devices that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.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.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an unspecified surgical procedure, the soctor had difficulty placing absolute intscr 9x23mm *ea device.According to the reporter, the end screw thread was different from the others.T was further reported that the thread was not uniform on both sides.At the end of the screw, the thread on one side was flattened.It was reported that the screw has never been used.The doctor tried to use it but was impossible and had to use another screw to complete the procedure.There was a delay of five minutes.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8266620
• Report Number: 1221934-2018-52783
• Device Sequence Number: 2370939
• Product Code: MAI
• UDI-Device Identifier: 10886705012978
• UDI-Public: 10886705012978
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/01/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 254505
• Device Lot Number: 3909633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2016
• Initial Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1