MAUDE Adverse Event Report: DEPUY MITEK LLC US 4.5 NG HEALIX CORTICAL AWL/TAP; BONE AWL

Catalog Number	222316
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: unavailable.
Event or Problem Description
It was reported by the sales representative that the awls in a healix advance instrument set (umhea05n) are very blunt and need to be replaced.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.The complaint device was received and evaluated.A visual inspection was performed to determine if the device had any gross visual defects that may contribute to the complaint condition.It was observed that the devices appears to be dull confirming the complaint condition.The root cause for the reported failure could be due to repeated use of the device over the years as from the lot number the device was around 6 years old.However,the definitive root cause cannot be determined.A manufacturing record evaluation was performed for the finished device product and lot 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.Device history a manufacturing record evaluation was performed for the finished device product and lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: investigation summary: the complaint device was not returned after multiple attempts for device return, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.Multiple follow ups were performed to obtain more information but no response was received.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.Should the device ever be received back in the future, this complaint file will be reopened at that time and an evaluation will be performed and documented.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.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.5 NG HEALIX CORTICAL AWL/TAP
• Common Device Name: BONE AWL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9166699
• Report Number: 1221934-2019-58835
• Device Sequence Number: 2763159
• Product Code: LXH
• UDI-Device Identifier: 10886705022410
• UDI-Public: 10886705022410
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 09/10/2019

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 Catalogue Number: 222316
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 11/01/2019; 11/14/2019; 12/06/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 11/11/2019; 12/02/2019; 12/09/2019
• Patient Sequence Number: 1