MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO INTERFERENCE SCREW, 8 X 30MM; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	231815
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/25/2013
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Evaluation statement: the complaint device was received and inspected.The anchor is broken near its distal end confirming this complaint.Visual observation of the broken anchor indicates the external geometry of the screw was not damaged as the threads did not strip during insertion.No information was available regarding the instruments used during the procedure.We cannot discern a root cause for this failure mode.A batch record review has been conducted for this batch to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that a non-conformance was opened relating to the rinsing step of the sterilization cycle, the air injection time exceeded the specification with a time of 58 minutes whereas the specification is between 20 and 45 min.Sterilization department further confirms that this issue has no adverse effect to the product sterility, residuals or functionality or performance of the products.Further, a review into the depuy 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 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 remetrex complaint management system 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 our affiliate that a screw broke while being inserted.It was noted that the screw broke during the first movement without pressure.The procedure was completed using a like product.

• Brand Name: MILAGRO INTERFERENCE SCREW, 8 X 30MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7673573
• Report Number: 1221934-2018-51125
• Device Sequence Number: 11131493
• Product Code: MAI
• UDI-Device Identifier: 10886705010783
• UDI-Public: 10886705010783
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/08/2013

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2015
• Device Catalogue Number: 231815
• Device Lot Number: 3638606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2013
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2013
• Initial Report FDA Received Date: 07/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1