MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO ADVANCE SCREW 8X30MM; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	231821
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.(b)(4).The exp date is currently unavailable.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.This failure could be attributed to user technique issue.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.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.
Event or Problem Description
This is report 1 of 2 for the same event.It was reported by the affiliate in (b)(6) that during an unspecified surgical procedure, it was observed that the milagro advance screw 8x30mm device broke during the screw-insertion over the guide-wire with the universal-screwdriver.It was an 7mm tibia-tunnel, with a short distal drill 8.5.The surgeon took the pieces out and insert a new one but it also broke.It was reported that the second one stayed in the patient as the screw broke near the screw-head.It was reported that the second screw was inserted into the same hole as well.There was no delay of greater than 30 minutes in the surgical procedure.There was patient involvement reported.There were no injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
Product complaint # (b)(4).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 additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).The exp date is currently unavailable.Correction: no nonconformances were identified for this part-lot number combination.

• Brand Name: MILAGRO ADVANCE SCREW 8X30MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8281919
• Report Number: 1221934-2018-51684
• Device Sequence Number: 1952856
• Product Code: HWC
• UDI-Device Identifier: 10886705022267
• UDI-Public: 10886705022267
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K123362
• 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): 06/01/2016

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: 231821
• Device Lot Number: 3784128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2016
• Initial Date Received by Manufacturer: 06/01/2016
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 01/28/2019
• Supplement Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1