MAUDE Adverse Event Report: DEPUY MITEK LLC US 35MM MODULAR DRIVER - MILAGRO ADVANCE; SURGICAL SCREWDRIVER, REUSABLE

Catalog Number	219500
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(b)(4).Associated medwatch: 1221934-2018-50760.
Event or Problem Description
It was reported via phone by the sales rep that during an acl procedure, the customer's milagro advance driver tip stripped and broke off in the screw.The doctor tapped the bone first, but stated the patient had hard bone.The doctor was able to remove the tip from the screw and used another like device to complete the procedure.There were no patient consequences or delays.The complaint devices are being returned.
Additional Manufacturer Narrative
Product complaint # (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.
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.Device received on 6-6-2018.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Associated medwatch: 1221934-2018-50760.
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 dfa.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 device was received and inspected.The complaint cannot be confirmed.Visual observation revealed no gross visual defects, and the distal tip of the driver was not damaged at all.A device history record (dhr) review has been conducted to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident; therefore, there is no evidence of manufacturing anomalies on the paperwork reviewed.At this point, 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
Additional information received on 5/22/2018.It was reported by the rep that the breakage occured intra-op but didn't result in any surgical delays.It was reported that the doctor was able to remove the broken part.The procedure was completed using another device and alternatives were readily available.Hard bone may have contributed to the breakage.Surgical intervention wasn't planned.There were no portion of the device remain in the patient and no patient impact.

• Brand Name: 35MM MODULAR DRIVER - MILAGRO ADVANCE
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 7536982
• Report Number: 1221934-2018-50759
• Device Sequence Number: 11215957
• Product Code: LXH
• UDI-Device Identifier: 10886705023196
• UDI-Public: 10886705023196
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/06/2018

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 Catalogue Number: 219500
• Device Lot Number: 1303001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Initial Date Received by Manufacturer: 04/27/2018
• Supplement Date Received by Manufacturer: 06/06/2018; 05/22/2018; 10/25/2018
• Initial Report FDA Received Date: 05/23/2018
• Supplement Report FDA Received Date: 07/02/2018; 10/29/2018; 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1