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

Catalog Number	231810
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional 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 is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A non-conformance search was performed for this part-lot combination and no non-conformances were identified.It is mentioned in the event description that the patient had hard bone quality.Hence , one of the possibilities of the reported complaint could be that the surgeon applied too much pressure during insertion causing the device to crack.However, we do not have the physical device available to confirm the complaint.No further information regarding the technique or instruments used has been provided to determine a definite root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, no corrective action is required, and no further action is warranted.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.(b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during an acl reconstruction procedure the sales rep's 8x23mm milagro interference screw cracked while inserting into the patient.The sales rep stated that there was a linear crack on the face of the screw.The screw was backed out of the patient with a driver with no debris left behind.The sales rep stated that the patient had hard bone quality.The case was completed with another like-implant with no patient harm or delay.There is no need for surgical intervention.The device was discarded by the customer.

• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8345097
• Report Number: 1221934-2019-56419
• Device Sequence Number: 1734041
• Product Code: MAI
• UDI-Device Identifier: 10886705010776
• UDI-Public: 10886705010776
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/01/2019

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: 08/31/2020
• Device Catalogue Number: 231810
• Device Lot Number: L553172
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/01/2019
• Initial Report FDA Received Date: 02/15/2019
• Patient Sequence Number: 1