MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO ADVANCE SCREW 10X23MM; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	231819
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2018
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.Udi: (b)(4) -incomplete.The expiration date is currently unavailable.Associated medwatch: [mr#1221934-2018-51849].
Event or Problem Description
It was reported by the sales rep via phone that during an acl procedure the new tech handed the surgeon a 33mm driver to insert the customer's milagro advance screw 9x23mm and the screw cracked.The issue occurred again with the customer's milagro advance screw 10x23mm.The sales rep stated that the surgeon was able to back out both devices with no issues and that both devices did not break into two or more pieces.The procedure was completed with other like devices using the same hole with no harm to the patient or delays to the case.The sales rep stated that the devices were discarded by the customer.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the complaint device was discarded by the customer therefore, device is not available for a physical evaluation.This complaint is not confirmed.It was reported that the milagro advance screw cracked during insertion.No further information regarding the procedure, patient condition or the device used has been provided to determine a root cause for this failure.The dhr review indicated that this batch of devices were processed without incident, therefore, there is no evidence of manufacturing anomalies on the records reviewed.Further, a review of the depuy synthes mitek complaints system revealed no complaints of any type for this lot of devices that were released to distribution.Based on the information available this complaint will be accounted for and monitored via post market surveillance activities.However, if additional information is made available, the investigation will be updated as applicable.At this point in time, no corrective action is required, and no further action is warranted.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.Udi: (b)(4).Associated medwatch: [mr#1221934-2018-51849].

• Brand Name: MILAGRO ADVANCE SCREW 10X23MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7601604
• Report Number: 1221934-2018-51850
• Device Sequence Number: 13521926
• Product Code: MAI
• UDI-Device Identifier: 10886705022236
• UDI-Public: 10886705022236
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K123362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2018

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: 05/31/2018
• Device Catalogue Number: 231819
• Device Lot Number: 3845289
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 08/03/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 08/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1