MAUDE Adverse Event Report: DEPUY MITEK LLC US 10 X 30MM MILAGRO INTERFERENCE SCREW; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	231840
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2016
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.(b)(4).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.The complaint device is not being returned, therefore unavailable for a physical evaluation.A review into the depuy synthes mitek complaints system revealed no other complaints for this lot of devices that were released to distribution.We cannot discern a root cause for the reported failure mode.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.
Event or Problem Description
It was reported that during an acl repair that the threads on the customer's milagro interference screw 10 x 30mm became damaged when the screw was being inserted into the bone tunnel.It was reported that during use the surgeon did not notch and the tunnel was too tight causing to the screw to break when fully inserted.The surgeon removed the screw leaving nothing in the patient.The surgeon completed the procedure with another same type screw in the same bone tunnel with no patient consequences or delays.
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.Additional 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).This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.Missing data from investigation and complete udi provided: a non-conformance search was performed for this part#: 231840 lot#:3706180 combination and no nonconformances were identified.

• Brand Name: 10 X 30MM MILAGRO INTERFERENCE SCREW
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8277956
• Report Number: 1221934-2018-51385
• Device Sequence Number: 16733710
• Product Code: MAI
• UDI-Device Identifier: 10886705010837
• UDI-Public: 10886705010837
• Combination Product (Y/N): N
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2016

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 Expiration Date: 05/31/2016
• Device Catalogue Number: 231840
• Device Lot Number: 3706180
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2016
• Supplement Date Received by Manufacturer: 03/21/2016
• Initial Report FDA Received Date: 01/25/2019
• Supplement Report FDA Received Date: 01/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1