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

Catalog Number	222223
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/17/2019
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: (b)(4).
Event or Problem Description
It was reported by the sales rep via phone that during a rotator cuff repair procedure it was found that the laser lines on the customer's healix awl are faded and the tip of the device is dull.The procedure was able to be completed with the device with no patient harm or surgical delay to the case.The sales rep was not present for the case therefore could not provide any further information.The device will be returning for evaluation.
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.Investigation summary: this complaint device was received and visually inspected.Visual observation confirms the laser line is faded.The other laser markings are also faded.This device is more almost 10 years old and its visual appearance indicate possible heavy use.Repeated use/ sterilization cycles further contribute to this failure mode.This failure can be attributed to normal field wear.Also the sharp tip at the distal end appears to be flattened, confirming this failure.Historically, this type of failure has been observed when the device might have been dropped or device was tapped at an off angle or hit the bone accidentally at an off angle.It cannot be determined at what point in time this failure occurred.A manufacturing record evaluation was performed for the finished device product and lot number, and no non-conformances were identified.At this point, 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.Udi:(b)(4).

• 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: 9338073
• Report Number: 1221934-2019-59568
• Device Sequence Number: 11311619
• Product Code: LXH
• UDI-Device Identifier: 10886705007707
• UDI-Public: 10886705007707
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 10/22/2019

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: 222223
• Device Lot Number: 0906001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 11/18/2019
• Supplement Report FDA Received Date: 12/20/2019
• Patient Sequence Number: 1