MAUDE Adverse Event Report: DEPUY MITEK LLC US 5.5/6.5 HEALIX ADVANCE AW; BONE AWL

Model Number	222315
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: initial reporter is synthes sales representative.The investigation could not be completed; no conclusion could be drawn, as no product was received.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.
Event or Problem Description
It was reported that on (b)(6) 2019, that at the end of the rotator cuff repair procedure the healix advance awl was dull.The procedure was completed with the same device.There was no patient consequence or surgical delay.This report is for one (1) 5.5/6.5 healix advance aw.This is report 1 of 1 for (b)(4).
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 is not being returned, it was discarded by the customer, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 1611001 number, and no non-conformances were identified.Since the complaint device was discarded, we cannot determine a root cause for the reported failure.If additional information is received in the future, we will reopen the complaint and perform the investigation as appropriate.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.A manufacturing record evaluation was performed for the finished device 1611001 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.

• Brand Name: 5.5/6.5 HEALIX ADVANCE AW
• Common Device Name: BONE AWL
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9224751
• Report Number: 1221934-2019-59160
• Device Sequence Number: 1564690
• Product Code: LXH
• UDI-Device Identifier: 10886705022465
• UDI-Public: (01)10886705022465
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2019

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: No Information
• Device Model Number: 222315
• Device Catalogue Number: 222315
• Device Lot Number: 1611001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 10/23/2019
• Supplement Report FDA Received Date: 11/20/2019
• Patient Sequence Number: 1