MAUDE Adverse Event Report: DEPUY MITEK LLC US ULTRA AGGRESSIVE PLUS 5.0 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Catalog Number 283729

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2019

Event Type  malfunction  

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.Initial reporter phone number (b)(6).Udi: (b)(4).

Event Description

It was reported by the affiliate via email that during a rotator cuff repair metal debris came out of the ultra aggressive plus 5.0 5pk, as per surgeon the device had only been used for about 30 seconds before seeing a small piece of metal in the joint.No patient consequence and no surgical delay was reported.No additional information was provided.Additional information provided by the affiliate reported adverse events did not occur to the patient.The affiliate reported the surgeon noticed the reported malfunction quite early in the procedure and was able to easily remove visible shavings with a new shaver.It was reported that it was impossible to know if all shavings were removed and a very minor surgical delay of one minute occurred.

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, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (m1809010), and no non-conformances related to the reported complaint condition 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.A manufacturer record evaluation was performed and results were obtained as follows: product : 283729.Lot number : m1809010.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.

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.The complaint device is not being returned, it was discarded, therefore unavailable for a physical evaluation.This complaint cannot be confirmed.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported failure.A manufacturing record evaluation was performed for the finished device lot number (m1809010), and no non-conformances related to the reported complaint condition 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 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: ULTRA AGGRESSIVE PLUS 5.0 5PK
• Type of Device: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 9335619
• MDR Text Key: 207396107
• Report Number: 1221934-2019-59563
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705022083
• UDI-Public: 10886705022083
• Combination Product (y/n): N
• PMA/PMN Number: K041824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 283729
• Device Lot Number: M1809010
• Date Manufacturer Received: 11/25/2019
• Patient Sequence Number: 1