MAUDE Adverse Event Report: DEPUY MITEK LLC US MILAGRO ADVANCE SCREW 10X23MM; ORTHOPAEDIC BONE SCREW, BIOABSORBABLE

Model Number	231819
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional pro-codes.Complainant part is not expected to be returned for manufacturer review/investigation.Investigation summary: the complaint device is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.No non-conformance's were identified for this part-lot number combination per qlik query executed 08/11/2019.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 lot no non-conformance's were identified for this part-lot number combination per qlik query executed 08/11/2019.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.
Event or Problem Description
It was reported by the sales rep via phone that during an acl procedure their intrafix advance br screw 10 x 30 mm with large sheath when the screw was inserted into the sheath, the sheath did not hold in the patient.When they tried their 10 x 23 mm milagro advance interference screw that also did not hold in the patient.The procedure was complete with a competitor's device with a new bone hole created.There was no patient consequences but there was a 20 minute surgical delay to the case.The sales rep stated that the patient was an older person with soft bone quality.The sales rep stated that the devices were discarded by the customer.This report is for one (1) milagro advance screw 10 x 23 mm.This report is 2 of 2 for (b)(4).

• Brand Name: MILAGRO ADVANCE SCREW 10X23MM
• Common Device Name: ORTHOPAEDIC BONE SCREW, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8895287
• Report Number: 1221934-2019-58007
• Device Sequence Number: 1617603
• Product Code: HWC
• UDI-Device Identifier: 10886705022236
• UDI-Public: (01)10886705022236
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K123362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/17/2019

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: 12/31/2021
• Device Model Number: 231819
• Device Catalogue Number: 231819
• Device Lot Number: 2L82089
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2019
• Initial Report FDA Received Date: 08/14/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention