MAUDE Adverse Event Report: DEPUY MITEK LLC US TIBIAL GUIDE ARM - TIP AIMER; BONENAIL GUIDEWIRE

Model Number	219393
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).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 affiliate in (b)(6) that during inspection on (b)(6) 2020, it was observed that the tibial guide arm - tip aimer device was corroded.There was no procedure involved.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.D9, 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, it was reported that the articles rust.The complaint device was received and evaluated.Visual observation.The complaint can be confirmed.The possible root cause could be attributed to fair wear and tear from the repeated use and sterilization cycles.The recommendation of the proper condition during the sterilization and maintenance to avoid any damage.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.

• Brand Name: TIBIAL GUIDE ARM - TIP AIMER
• Common Device Name: BONENAIL GUIDEWIRE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11089207
• Report Number: 1221934-2020-04121
• Device Sequence Number: 19723113
• Product Code: FZX
• UDI-Device Identifier: 10886705006229
• UDI-Public: 10886705006229
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/15/2020

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: 219393
• Device Catalogue Number: 219393
• Device Lot Number: NW242083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 01/08/2021; 02/05/2021; 02/09/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 01/11/2021; 02/08/2021; 02/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1