MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO INSCR SMALL SIZE 5X30; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Catalog Number	231804
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Patient identifier: (b)(6).Investigation summary: the complaint device is not being returned, it was implanted in the patient, therefore, unavailable for a physical evaluation.This complaint cannot be confirmed.No non-conformances were identified for this part-lot number combination per qlik query executed 03/25/2019.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.Udi: (b)(4).
Event or Problem Description
It was reported by the sales rep via cst that during a medical patellafemoral reconstruction procedure, two milagro interference screws broke during insertion.The sales rep stated the doctor was using two lupines and two milagro interference screws with an allograft.After secure fixation of the graft to the patella using the two lupines, the surgeon drilled the femoral tunnel and pulled the graft through.The first milagro interference screw tip broke off during insertion.The surgeon then attempted to use a second milagro interference screw and this implant also broke while inserting.Deeming enough fixation was accomplished even with the broken tips of the implants remaining in the patient, the case was finished and the fragments were not removed.There was a five minute delay to the case to open the new implant.

• Brand Name: MILAGRO INSCR SMALL SIZE 5X30
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8509892
• Report Number: 1221934-2019-56832
• Device Sequence Number: 1253242
• Product Code: MAI
• UDI-Device Identifier: 10886705010721
• UDI-Public: 10886705010721
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2019

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: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 231804
• Device Lot Number: L630312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 04/12/2019
• Patient Sequence Number: 1
• Patient Age: 16 YR