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

Catalog Number	231810
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).Investigation summary: the complaint device is not being returned, therefore, unavailable for a physical evaluation.This complaint cannot be confirmed.No non-conformances were identified for this part number (231810), lot number (l964388) combination per qlik query executed on 4/12/2019.No further information regarding the technique or instruments used has been provided to determine a 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.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during a rotator cuff repair procedure, it was observed that the tip of the 8x23mm milagro screw was smashed so that the surgeon could not insert the screw into the patient's body.The surgery was finished without any other problem, although it was not reported how the surgery was completed.It was brand new and the first use when the issue occurred.There was no surgical delay and no harm to the patient.No further information was provided by the hospital.

• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8581858
• Report Number: 1221934-2019-57006
• Device Sequence Number: 14046442
• Product Code: MAI
• UDI-Device Identifier: 10886705010776
• UDI-Public: 10886705010776
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 04/10/2019

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: 07/31/2021
• Device Catalogue Number: 231810
• Device Lot Number: L964388
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2019
• Initial Report FDA Received Date: 05/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1