MAUDE Adverse Event Report: DEPUY MITEK LLC US NCHPLSTY AWL FEM 45 RND *EA; BONE AWL

Model Number	219313
Medical Device Problem Codes	Dull, Blunt (2407); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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.(b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during an acl procedure these restore femoral awl devices were dull and slightly bent.Another device was used to complete the procedure.No patient consequences or surgical delay reported.These devices will return for evaluation.
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, depu to the potential ev treatment, not diagnosis.If information is obtained that was not available.If information is obtained that was not available for the initial medwatch, a follow-up melaatch will be filed as appropriate.H10 additional narrative: investigation summary: according to the information provided, it was reported that the device was dull and slightly bent.The complaint device is not being returned, multiples attempts for product return were made with no response, therefore unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Given that an invalid lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.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: BONE AWL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9678379
• Report Number: 1221934-2020-00506
• Device Sequence Number: 502147
• Product Code: LXH
• UDI-Device Identifier: 10886705005680
• UDI-Public: 10886705005680
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2020

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: 219313
• Device Catalogue Number: 219313
• Device Lot Number: 277462
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 03/12/2020
• Patient Sequence Number: 1