MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO INTSCR 9X23MM; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Model Number	231820
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.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
It was reported that during a reconstruction of the anterior cruciate ligament, at the end of introducing a miragro screw to hold a bone-tendon-bone graft, the screw was broken into several pieces.Some of the fragments were able to be removed, but the tip of the screw was left inside the femoral tunnel and holding the graft.The fragments of the screw that remained intra-articular after the rupture of the implant could be removed and only one of the fragments remained inside the tunnel, fixing the graft and could not extract.The surgeon performed a stability test of the ligament with the fragment that remained inside the femoral tunnel and decided not to include another means of fixation since the graft was fixed with the fragment of the screw that remained implanted.The procedure was delayed by 15 minutes but successfully completed.This is report 1 of 1 for (b)(4).
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.Investigation summary :the complaint device was received and was evaluated.Visual observation confirms that the screw had broken with missing pieces or fragments.This complaint can be confirmed.It is possible that excessive force was applied while screwing the miragro screw causing it to break.Other than the possibility of this occurrence, we cannot determine a root cause for this failure.No nonconformances were identified for this part-lot number combination per qlik query executed 04/24/2019.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.Udi: (b)(4).
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 additional information should become available, a supplemental medwatch will be submitted accordingly.Udi: (b)(4).Investigation summary: a part of the complaint device remains implanted into the patient.Follow-ups were done for product return of the broken fragments, but there was no response after multiple attempts.Hence, the device is unavailable for physical evaluation.This complaint cannot be confirmed.No nonconformances were identified for this part-lot number combination per qlik query executed (b)(6) 2019.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.
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 narrative: adverse event.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.
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.H10 additional narrative: d10 h3, h6: the device was received, the investigation is in progress, 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.

• Brand Name: MILAGRO INTSCR 9X23MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8514616
• Report Number: 1221934-2019-56845
• Device Sequence Number: 1884876
• Product Code: MAI
• UDI-Device Identifier: 10886705010790
• UDI-Public: (01)10886705010790
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K150209
• 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,Followup,Followup,Followup
• Report Date (Section B): 03/19/2019

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: 04/30/2021
• Device Model Number: 231820
• Device Catalogue Number: 231820
• Device Lot Number: L883019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 04/15/2019; 04/25/2019; 10/08/2019; 12/31/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 04/15/2019; 05/08/2019; 11/04/2019; 12/31/2019
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Weight: 96