MAUDE Adverse Event Report: DEPUY MITEK LLC US 10X30 MM MILAGRO ADVANCE INTERFERENCE SCREW; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	231823
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2018
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.(b)(4).The expiration date is not currently available.
Event or Problem Description
It was reported that during an acl reconstruction procedure, the surgeon was using this 10 x 30mm screw on a 9mm tibial tunnel.The tip of the screw broke as he was inserting it.He discarded it and used another screw to complete the procedure.Successful reconstruction.No ae to patient.No delay to procedure.
Event or Problem Description
It was reported that during an acl reconstruction procedure, the surgeon was using this 10 x 30mm screw on a 9mm tibial tunnel.The tip of the screw broke as he was inserting it.He discarded it and used another screw to complete the procedure.Successful reconstruction.No ae to patient.No delay to procedure.Additional information provided by (b)(6) rep on 11 apr 2018: the fragments were retrieved using artery forceps.The patient had hard bone quality which might have contributed to the breakage.The insertion was not off-axis.The same bone hole was used to complete the procedure.The broken fragment was retrieved from the patient and the procedure completed successfully.
Additional Manufacturer Narrative
Udi: (b)(4) ¿incomplete.The expiration date is not currently available.
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.Additional information: the exp date was reported as unknown in the initial report and has been updated as 5/31/2020; therefore, udi: (b)(4).The complaint device was discarded by the customer therefore the device is not available for a physical evaluation.This complaint is not confirmed.Without physically evaluating the device, a definite root cause cannot be determined.Review of the device history record indicated that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the records reviewed.A review into the depuy synthes mitek complaints system revealed one similar complaint for this device's lot number.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.

• Brand Name: 10X30 MM MILAGRO ADVANCE 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: 7412202
• Report Number: 1221934-2018-50436
• Device Sequence Number: 1083976
• Product Code: HWC
• UDI-Device Identifier: 10886705022281
• UDI-Public: 10886705022281
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/13/2018

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: 05/31/2020
• Device Catalogue Number: 231823
• Device Lot Number: L421938
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 04/11/2018; 05/30/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 05/07/2018; 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1