MAUDE Adverse Event Report: DEPUY MITEK LLC US 8X30MM MILAGRO ADVANCE INTERFERENCE SCREW; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Model Number	231821
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional pro-code: mai.(b)(4).Device received.A review of the device history record has been requested.The investigation could not be completed; no conclusion could be drawn at the time of filing 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.
Event or Problem Description
Anchor was pulled out.It was reported that during the acl reconstruction, used screw driver to insert the anchor, when removed the driver, the screw also was pulled out.Changed another screw, the event re-happened.Changed another screw with this driver could insent anchor successfully.So the surgeon suspect it is related the anchors.There were no adverse consequences to the patient.No additional information could be provided.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.The complaint device was received and evaluated.Visual observation of the anchor under magnification revealed some small nicks in the exterior threads on the anchor.There were no other anomalies observed on the devices.The threads on the anchor appear stressed consistent with it being inserted into the bone.A hex driver was inserted into the anchor and seated properly.It was not difficult to remove the inserter from the anchor.It can be confirmed that this anchor pulled out.Typically, anchor pull outs are associated with incomplete insertion into the bone hole, using instruments not indicated to be used with the anchor, poor bone quality and applying excess force on suture during tensioning.Although we cannot discern a root cause, any of the aforementioned factors or a combination of factors could possibly lead to this failure.No nonconformances were identified for this part number, lot number combination per qlik query executed on 8/23/2019.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.Device history no nonconformances were identified for this part number, lot number combination per qlik query executed on 8/23/2019.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.

• Brand Name: 8X30MM 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: 9079632
• Report Number: 1221934-2019-58381
• Device Sequence Number: 2312649
• Product Code: HWC
• UDI-Device Identifier: 10886705022267
• UDI-Public: (01)10886705022267
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: No Information
• Device Expiration Date: 10/31/2020
• Device Model Number: 231821
• Device Catalogue Number: 231821
• Device Lot Number: L649470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 09/17/2019
• Supplement Report FDA Received Date: 11/12/2019
• Patient Sequence Number: 1