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

Model Number	231821
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inflammation (1932); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported by the affiliate via personal interaction that on (b)(6) 2020 the (b)(6) year-old female patient underwent an aclr (anterior cruciate ligament reconstruction).Grafts were fixated with a milagro 8x23 in the femoral burr hole.Next, other grafts were fixated in the tibial burr hole with the milagro advance 8x30 in question.Approximately two months passed when inflammation appeared in the incision lesion of the tibia.The suture was removed, and the lesion was re-sutured, which did not correct the inflammation.Finally, mri revealed some abnormalities such as an enlarged burr hole around the area where the milagro advance 8x30 was inserted.Graft survival was noticed to a certain extent.The milagro in question had kept its original shape.On (b)(6) the patient underwent a removal procedure.Currently she is under medical follow-up.Additional information could not be provided by the affiliate.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: the complaint device is not being returned, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (6l34837), and no non-conformities were identified.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.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.

• Brand Name: MILAGRO ADVANCE SCREW 8X30MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10487037
• Report Number: 1221934-2020-02367
• Device Sequence Number: 3860178
• Product Code: HWC
• UDI-Device Identifier: 10886705022267
• UDI-Public: 10886705022267
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K123362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 231821
• Device Catalogue Number: 231821
• Device Lot Number: 6L34837
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 10/06/2020
• Patient Sequence Number: 1
• Patient Age: 59 YR