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

Model Number	231809
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Tissue Damage (2104); No Code Available (3191)
Date of Event	01/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).The lot number is unknown.
Event or Problem Description
It was reported by affiliate via complaint submission tool that a month after procedure the milagro inscr small size 6x30 screw moved upwards into the joint space, as a consequence the patient had strange feeling in the popliteus, a surgery was performed and the surgeon was not able to remove the screw.The device is not available to be returned for evaluation.Additional information provided by the affiliate reported the surgeon reported the patient feels something disturbing to him near his popliteus.It was reported an x-ray is scheduled to occur some time soon but the exact time is unknown.The affiliate reported it was unknown if the screw has caused any addition harm or what the patient's prognosis maybe.It was also reported the lot number is unknown.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary = > the complaint device is not being returned, it was implanted in the patient, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.If any additional information is obtained, this complaint will be re-opened to capture that information.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.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.

• 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: 9890985
• Report Number: 1221934-2020-01005
• Device Sequence Number: 10971446
• Product Code: MAI
• UDI-Device Identifier: 10886705010769
• UDI-Public: 10886705010769
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 231809
• Device Catalogue Number: 231809
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 03/27/2020
• Supplement Report FDA Received Date: 04/09/2020
• Patient Sequence Number: 1