MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO INSCR SMALL SIZE 6X30; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	231809
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2016
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.The complaint device was received and evaluated.Visual observation confirms the screw is completely broke and there is a crack diagonally along the length of the screw.The threads of the screw were examined, and it was found to be distressed, which indicates that the failure happened during insertion.No other anomalies were found with the screw.Possible root causes could be that the patient had hard quality bone, and the user did not notch before inserting the screw.For hard bone, notching and tapping is required.Other than this possibility, we cannot discern a root cause for the reported failure.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this batch of devices that were released to distribution.A non-conformance search was performed for this part- lot combination and no non-conformances were identified.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, depuy synthes 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).Initial reporter phone number: (b)(6).The expiration date is unknown.
Event or Problem Description
Physician reported that screw is broken.No additional details available.

• Brand Name: MILAGRO INSCR SMALL SIZE 6X30
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8317418
• Report Number: 1221934-2018-52103
• Device Sequence Number: 13868871
• Product Code: MAI
• UDI-Device Identifier: 10886705010769
• UDI-Public: 10886705010769
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/01/2016

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 Catalogue Number: 231809
• Device Lot Number: 3795838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2016
• Initial Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1