MAUDE Adverse Event Report: DEPUY MITEK LLC US TIBIAL GUIDE RAIL; BONENAIL GUIDEWIRE

Model Number	219391
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(6).(b)(4).The lot number is unknown.
Event or Problem Description
It was reported by the affiliate via cst that during inspection of the orthokit the following devices were rusted: tibial guide rail, tibial guide arm-tip aimer, tibial guide bullet, cruciate + femoral capture, graft prep sys sliderunit (2 req) *ea.All devices are available to be returned for evaluation.
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, it was reported by the affiliate via cst that during inspection of the orthokit the following devices were rusted: tibial guide rail, tibial guide arm-tip aimer, tibial guide bullet, cruciate + femoral capture, graft prep sys sliderunit (2 req) *ea.All devices are available to be returned for evaluation.The complaint device was received and evaluated.Visual observation reveals that the device is worn which is consistent with the device usage.A few spots of corrosion can be observed on a side of the device.According with the visual inspection result, this complaint can be confirmed.The possible root cause for the reported condition can be attributed to the sterilization process in autoclave, the device was possibly left to dry along with other metal instruments resulting in galvanic corrosion.However, this cannot be conclusive determined.As a potential cause cannot be associated to manufacturing, therefore a manufacturing record evaluation is not required.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
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.

• Brand Name: TIBIAL GUIDE RAIL
• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10524049
• Report Number: 1221934-2020-02563
• Device Sequence Number: 3203838
• Product Code: FZX
• UDI-Device Identifier: 10886705006205
• UDI-Public: 10886705006205
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 08/28/2020

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: 219391
• Device Catalogue Number: 219391
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 10/07/2020; 10/16/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 10/08/2020; 10/19/2020
• Patient Sequence Number: 1