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

Model Number 283729

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).The lot number was unknown; therefore, the exp date was unknown.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.No additional information was provided.

Event Description

It was reported by the affiliate in (b)(6) that during a knee arthroscopy procedure on an unknown date, it was observed that the ultra aggressive plus 5.0 device had metal spreading while the foot pedal mode oscillated.A lavage was performed since fragments were generated but are still in the knee joint.It was reported that there was a five minute delay in the procedure.If there were any delays in the procedure or whether a like device was available for use.No additional information was provided.

Manufacturer Narrative

This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, 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.Investigation summary according to the information received, it was reported via complaint submission tool that during a knee arthroscopy while using a 5 mm ultra aggressive plus there was metal spreading.It happened with the foot pedal mode oscillate.The complaint device is not being returned, therefore unavailable for a physical evaluation.Given that lot number was not provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.This complaint cannot be confirmed.Since the complaint device not being returned, 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, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.

• 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: 11050049
• MDR Text Key: 225335805
• Report Number: 1221934-2020-03988
• 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
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 283729
• Device Catalogue Number: 283729
• Initial Date Manufacturer Received: 12/07/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 01/24/2021
• Supplement Dates FDA Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention