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

Model Number	219500
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 was unknown.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported by the sales rep that the 35mm modular driver - milagro advance was bent.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
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.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 appropriate.
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: according to the information provided, iit was reported that the 35mm modular driver - milagro advance was bent.The complaint device was received and evaluated.Marks on the distal part of the device were observed during the visual inspection, it was also noted that the modular drive it¿s bent, which confirms the customer complaint.The root cause of the marks and the bent condition can be attributed to the wear of the device since this is a reusable part.In addition, this type of failure may be related when the metal from an excessive of wear begins to lose the shape.However, it cannot be conclusively affirmed.A manufacturing record evaluation was performed for the finished device [1309001] number, and no non-conformances were identified.At this point, 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
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.The lot number has been updated to 1309001.Therefore, udi: (b)(4).:.

• Brand Name: MILAGRO ADVANCE MODULAR DRIVER
• Common Device Name: SURGICAL SCREWDRIVER, REUSABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10240762
• Report Number: 1221934-2020-01766
• Device Sequence Number: 19419444
• Product Code: LXH
• UDI-Device Identifier: 10886705023196
• UDI-Public: 10886705023196
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/22/2020

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 Model Number: 219500
• Device Catalogue Number: 219500
• Device Lot Number: 1309001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 07/08/2020; 08/07/2020; 08/10/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 07/10/2020; 08/10/2020; 08/12/2020
• Patient Sequence Number: 1