MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO INSCR SMALL SIZE 6X30; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	231809
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/02/2016
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.The complaint device was received and inspected.The anchor is broken near its distal end confirming this complaint.Visual observation of the broken anchor indicates the threads were distressed, which indicates that the device was inserted.No information was available regarding the instruments used during the procedure.One possible conclusion is this failure occurred due to the hard bone quality of the patient, as reported by the customer.We cannot discern a root cause outside this possibility at this point.Further, a review into the depuy synthes mitek complaints system revealed no other complaints of any type 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.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.No nonconformances were identified for this part-lot number combination per qlik query executed 11/13/2018.Review conducted per (b)(4).This report is being filed from the as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.(b)(4).
Event or Problem Description
It was reported that during mpfl reconstruction the surgeon used the device for graft fixation of the femur.It was reported that the tip of the device broke when he inserted the device in a 6mm bone hole after passing a graft through the bone hole and inserting a guide pin.He stopped using the device and successfully inserted a shorter size of the device (6x23mm).It was also reported that no broken piece was left in the patient¿s body.There was no surgical delay or harm to the patient.

• Brand Name: MILAGRO INSCR SMALL SIZE 6X30
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8288434
• Report Number: 1221934-2019-56246
• Device Sequence Number: 19448515
• Product Code: MAI
• UDI-Device Identifier: 10886705010769
• UDI-Public: 10886705010769
• 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
• Report Date (Section B): 08/02/2016

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: 231809
• Device Lot Number: 3829110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2016
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/02/2016
• Initial 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
• Patient Age: 18 YR