MAUDE Adverse Event Report: DEPUY MITEK LLC US LUPINE STABILIZATION FISHMOUTH DRGDE *EA; SURGICAL HAND DRILL

Model Number	213817
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4) incomplete.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 during a shoulder repair procedure, it was observed that two of the fishmouth drill guide and two of the drill bit (stabilization) were dull and created metal shavings.All fragments were retrieved from the patient´s body.The procedure was completed using the same device.No patient consequences or surgical delay reported.No additional information was provided.
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.Additional information: d4, h4: the lot number has been updated as 18f01 to reflect the correct information.Therefore, the device manufacture date and have been updated accordingly.Udi: (b)(4).
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: a manufacturing record evaluation was performed for the finished device [18f01] number, and no non-conformances were identified.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: correction: d10: the date device returned to manufacturer was reported as 7/24/2020 on the initial report and has been updated as 7/8/2020 to reflect the correct information.Device evaluation: investigation summary : according to the information provided, it was reported that during a shoulder repair procedure two of the fishmouth drill guide and two of the drill bit (stabilization) were dull and created metal shavings.The complaint device was received and inspected.Visually, the device appears worn.Also, the handle has nicks and marks.This failure could be attributed to normal field wear due to its condition.However, it cannot be conclusively affirmed.For further investigation, it was reviewed with the external manufacturer to determine additional information about if there were any internal issues which would have contributed to the nature of the product complaint.The device history record was made; as a result, the manufacture date was during june-august 2018.In the last 3 years, there are not similar complaints.In addition, this failure seems to be one off incident.A closer investigation about the fishmouth drill guide was performed; the engineering department concluded that it is important to follow the ifu-107066 instruction before used the device in the procedure.The main points are that it is necessary to inspect the damage prior use and the device is a delicate instrument because of this, required a cleaning processing specific to avoid damaging it.Therefore, the issue is not manufacturing related and we cannot confirmed this complaint.Since there are no more information of the defect reported we cannot discern a root cause, but it could be related to did not follow up the ifu instruction.A manufacturing record evaluation was performed for the finished device [18f01] number, and no non-conformances were identified.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.

• Common Device Name: SURGICAL HAND DRILL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10201774
• Report Number: 1221934-2020-01665
• Device Sequence Number: 16705898
• Product Code: FZX
• UDI-Device Identifier: 10886705003280
• UDI-Public: 10886705003280
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/10/2020

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: 213817
• Device Catalogue Number: 213817
• Device Lot Number: 18F01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 06/29/2020; 07/24/2020; 08/06/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 06/30/2020; 07/27/2020; 08/07/2020
• Patient Sequence Number: 1