MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL MILAGRO ADV PEEK SCREW 9X30MM; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	231868
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.Udi: (b)(4).The lot number is unknown.
Event or Problem Description
It was reported by the sales rep via complaint submission tool that following an acl procedure the milagro adv peek screw 9x30 mm infected the patient.No additional information was 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.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.H10 additional narrative: additional information: b5: subsequent follow-up with the customer, additional information was received.It was reported that the surgeon took the screw out.
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.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.H10 additional narrative: correction: d10, h3: it was inadvertently reported on the previous report that the device was returned for evaluation.However, upon complaint review, it was determined that the complaint sample was not available for return.Both fields have been updated accocrdingly to reflect the correct information.Additional information: investigation summary: the complaint device is not being returned, it was implanted in the patient, 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 issue.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.Also, we cannot review the sterile load information as the lot number was not provided.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
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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 data provided by the affiliate reported patient experienced a postoperative infection of right knee with staphylococcus aureus which was treated with amoxicillin 2 x 1 for 10 days as well as a re-arthroscopy for irrigation and debridement of the knee.
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.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.H6: the patient codes were inadvertently missed on the previous report and have been updated to reflect the correct information.Patient code 3191 (no code available) was used to capture surgical intervention.D10, h3, h6: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as app.

• Brand Name: MILAGRO ADV PEEK SCREW 9X30MM
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 9886478
• Report Number: 1221934-2020-00997
• Device Sequence Number: 14089994
• Product Code: MBI
• UDI-Device Identifier: 10886705026449
• UDI-Public: 10886705026449
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K161001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/12/2020

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 Model Number: 231868
• Device Catalogue Number: 231868
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 03/30/2020; 04/03/2020; 03/30/2020; 04/13/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 04/01/2020; 04/03/2020; 04/07/2020; 04/13/2020
• Patient Sequence Number: 1