MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO ADVANCE SCREW 9X30MM; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	231822
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Associated medwatch: 1221934-2018-54635.
Event or Problem Description
It was reported by the affiliate that during acl procedure two milagro interference screws broke intraoperatively while screwing in and there was no patient harm indicated.Additional information from affiliate 8/29/2018: the upper part of the implant broke.The patient¿s bone quality was standard.No information on how the case was completed.No surgical delay.The surgeon/doctor was not off axis.The same bone hole was used to complete the procedure.Implant was removed and no debris was left in the patient.
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.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.Evaluation statement: the complaint device was received and evaluated.Visual observations revealed that the distal tip of the device was broken and the threads appear to be worn.Therefore, this complaint can be confirmed.The information provided stated that the surgeon was not off axis and the patient had standard bone quality.We cannot discern a definitive root cause for the reported failure, however, if there was a possibility that the bone hole was not prepared properly, this could have caused the failure.Furthermore, a nonconformance search was conducted and no nonconformances have been identified for this part 231822 with lot l926609 combination.At this point, 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.Udi: (b)(4).Associated medwatch report number: 1221934-2018-54635.

• Brand Name: MILAGRO ADVANCE SCREW 9X30MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7869635
• Report Number: 1221934-2018-54634
• Device Sequence Number: 1720342
• Product Code: HWC
• UDI-Device Identifier: 10886705022274
• UDI-Public: 10886705022274
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/21/2018

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: 05/31/2021
• Device Catalogue Number: 231822
• Device Lot Number: L926609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 11/15/2018
• Patient Sequence Number: 1