MAUDE Adverse Event Report: DEPUY MITEK 5 MM AGGRESSIVE BLADE PLUS; ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE

Catalog Number 283719

Device Problem Metal Shedding Debris (1804)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/28/2017

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4) - incomplete; the expiration date is currently unavailable.

Event Description

The affiliate reported via email that during a surgical acromioclavicular joint reconstruction and biceps tenodesis, team opened as the disposable component for a shaver handpiece, placed in the shoulder joint arthroscopically, when used the burr began to produce metal fragments.Item removed and new burr used without issue.Surgeon wished incident form for any possible issues with metal shards in the shoulder joint.No part of item 'missing'.Need investigation as to why fragments were released.Action taken to manage problem: extra irrigation, new burr opened.5 minute delay to procedure.No adverse event to patient.Additional information received via email from the affiliate on 9-19-2017: to be confirmed how many passes were made prior to the break.To be confirmed when the breakage occurred.The assumption is yes that alternatives were readily available as there was no surgical delay reported.To be confirmed if there were any procedural or patient anatomy.Factors which may have contributed to the breakage.There is no surgical intervention planned.

Manufacturer Narrative

This emdr is being resubmitted due to an esg or cdrh emdr processing system outage.This report was originally submitted on october 30, 2017; however, the system problem prevented acknowledgements from being received.(b)(4).

Manufacturer Narrative

The device was received and visually inspected under magnification; no anomalies were found.The blade was then evaluated with the quality engineer responsible for the product.Performed oscillation at 2500 rpm by connecting it to the fms pump to look for any metal shavings.Further a forward mode test at 6000 rpm was performed for around 2 minutes, looking for any anomalies.There were no metal shavings observed during either test, this complaint cannot be confirmed.A root cause for the user to have experienced this issue cannot be determined.A review in to our complaint file revealed no other complaints for this device's lot number released for distribution.A device history record review has been conducted for this lot number to determine if there were any internal processing issues which would have contributed to the nature of the product complaint.Our results indicate that this batch of product was processed without incident and therefore there is no evidence of manufacturing anomalies on the paperwork reviewed.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: 5 MM AGGRESSIVE BLADE PLUS
• Type of Device: ARTHROSCOPIC SHAVER SYSTEM BLADE, SINGLE-USE
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: jennifer lawrence ; 325 paramount drive; raynham, MA 02767 ; 5089776860
• MDR Report Key: 6893381
• MDR Text Key: 87350240
• Report Number: 1221934-2017-10533
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041824
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/28/2017

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 Expiration Date: 01/31/2018
• Device Catalogue Number: 283719
• Device Lot Number: M1311002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2017
• Initial Date Manufacturer Received: 08/28/2017
• Initial Date FDA Received: 09/26/2017
• Supplement Dates Manufacturer Received: 10/02/2017; 11/15/2017
• Supplement Dates FDA Received: 11/03/2017; 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other