MAUDE Adverse Event Report: DEPUY MITEK LLC US HEALIX AWL -NS; BONE AWL

Model Number	222223
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint #: (b)(4).Device was used for treatment, not diagnosis.Udi: (b)(4).
Event or Problem Description
It was reported by the sales rep via complaint submission tool that when performing a shoulder rotator cuff repair when the healix awl ns was being used it was noticed that the laser line was completely dull and was not able to properly locate the depth to mallet.A second 4.75 healix advance kntlss pk that the facility owned was intended to be used however the top of the awl was slightly bent.The procedure was completed using another device.No patient consequence and no surgical delay was reported.No additional information was provided.An email received from the affiliate clarified the second product code 222223, lot 1408002, healix awl.
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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.Investigation summary according to the information provided, it was reported that during a shoulder rotator cuff repair when the healix awl -ns was being used it was noticed that the laser line was completely dull and was not able to properly locate the depth to mallet.A second 4.75 healix advance kntlss pk that the facility owned was intended to be used however the top of the awl was slightly bent.The complaint device is not being returned, 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.  a manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), 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 lot a manufacturing record evaluation was performed for the finished device lot/serial number (b)(6), and no non-conformances were identified.

• Brand Name: HEALIX AWL -NS
• Common Device Name: BONE AWL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9732460
• Report Number: 1221934-2020-00626
• Device Sequence Number: 3098406
• Product Code: LXH
• UDI-Device Identifier: 10886705007707
• UDI-Public: 10886705007707
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2020

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: 222223
• Device Catalogue Number: 222223
• Device Lot Number: 1408002
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 02/20/2020
• Supplement Report FDA Received Date: 04/07/2020
• Patient Sequence Number: 1