MAUDE Adverse Event Report: DEPUY MITEK LLC US LATARJET CURVED OSTEOTOME; ORTHOPAEDIC OSTEOTOME

Model Number	285270
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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.Udi: (b)(4).
Event or Problem Description
It was reported via complaint submission tool that the loan kit technician reported that during loan kit inspection, when impacting head/area of a curved osteotome handle has broken off (not returned).It has been forwarded to depuy engineering for assessment.No further information can be obtained as the case was not reported by the customer.
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: h6: method codes: a manufacturing record evaluation was performed for the finished device [14c01] 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.Investigation summary =according to the information provided, it was reported that during loan kit inspection, when impacting head/area of a curved osteotome handle has broken off (not returned).The complaint device was received and evaluated.Visual observations reveals that the osteotome is slightly worn and used, but in expected condition.When inspecting at the handle¿s area, some malleting marks could be observed, the handle¿s cap is missing and broken due to the hard use.According with the visual inspection result, this complaint can be confirmed.The possible root cause for the broken handle's cap can be attributed to the constant hard use of the device and malleting, however this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device [14c01] number, and no non-conformances were identified.At this time, no corrective action is required, and no further action is warranted, as the device is fully functional.However, depuy synthes mitek will continue to track any related complaints within this device family to monitor the extent to which this complaint is observed in the field.

• Brand Name: LATARJET CURVED OSTEOTOME
• Common Device Name: ORTHOPAEDIC OSTEOTOME
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10603516
• Report Number: 1221934-2020-02798
• Device Sequence Number: 14364909
• Product Code: LXH
• UDI-Device Identifier: 10886705018000
• UDI-Public: 10886705018000
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 09/15/2020

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: 285270
• Device Catalogue Number: 285270
• Device Lot Number: 14C01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 10/05/2020; 10/15/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 10/09/2020; 10/16/2020
• Patient Sequence Number: 1