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	Not Applicable (3189)
Date of Event	12/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4)-incomplete.The lot number is currently unavailable; therefore, the exp date is unavailable.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.At this point in time, 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.
Event or Problem Description
It was reported by the sales rep in (b)(6) that during anterior cruciate ligament surgical procedure, it was observed that a nitinol guidewire (from arthrex) broke during insertion of a milagro advance screw for tibia fixation.The nitinol piece was found in the graft so that the surgeon could take it away.There was a delay of 30 minutes but no consequences to the patient.The surgeon used a 9x30 milagro advance with semit in a tunnel of 9.A re-acl with filled bone (allograft) was involved in the procedure.The surgeon concluded that it too much to put a milagro of 10, so a 9er was taken.But after the issue the surgeon concluded that an undersizing would have been better.The nitinol guidewire piece was found with a ct and removed.Also the screw was removed and a new one was inserted.The procedure was successfully completed.Fragments were generated but were removed easily using x-rays to find the nitinol guidewire piece.No other additional intervention was required.It is unknown if the patient was a part of a clinical study.There was patient involvement reported.There were no reports of 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.

• 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: 8217164
• Report Number: 1221934-2019-55904
• Device Sequence Number: 1710321
• Product Code: HWC
• UDI-Device Identifier: 10886705022274
• UDI-Public: 10886705022274
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Report Date (Section B): 12/22/2018

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 Catalogue Number: 231822
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/22/2018
• Initial Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 22 YR