MAUDE Adverse Event Report: DEPUY MITEK LLC US FULL RADIUS 4.0MM 5PK; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Catalog Number 283409

Device Problem Peeled/Delaminated (1454)

Patient Problem Not Applicable (3189)

Event Date 02/06/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).

Event Description

It was reported by the affiliate via cst tool that during a rotator cuff repair the device had metal shedding.There was a 10 minute delay to the procedure and the shavings were washed out of the joint.The affiliate reported that there was no patient harm.Additional information received from the affiliate on 02/12/2019 reporting that the procedure was completed with another readily available device.The affiliate also reported that 2 devices were impacted but only 1 device will be returning for an evaluation because the other device was discarded.

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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.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 (283409, lot : m1706002), and no non-conformances were identified.No further information regarding the technique or instruments used has been provided to determine a root cause for this failure.If any additional information is obtained, this complaint will be re-opened to capture that information.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.Udi: (b)(4).

• Brand Name: FULL RADIUS 4.0MM 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: 8395489
• MDR Text Key: 138240811
• Report Number: 1221934-2019-56571
• Device Sequence Number: 1
• Product Code: HRX
• UDI-Device Identifier: 10886705022014
• UDI-Public: 10886705022014
• 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
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 283409
• Device Lot Number: M1706002
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/07/2019
• Patient Sequence Number: 1