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

Catalog Number 283409

Device Problem Suction Failure (4039)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 08/31/2018

Event Type  Injury  

Manufacturer Narrative

(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 that during an unknown operation the product (product code: 283409, lot # m1802018) defaulted and resulted in the patient¿s shoulder filling up with debris.

Event Description

It was reported by the affiliate via e-mail that device with product code 283409 lot #m1802018 failed and resulted in the patient's shoulder filling up with debris during the operation.Additional information received on november 13, 2018, when the shaver was turned on and metal debris was deposited into the joint.Reporter confirmed prior to the shaver being used, there was no metal debris in the joint.The metal debris was flushed out as best as possible but not sure that nothing left into patient.The patient has been discharged at present.

Manufacturer Narrative

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

Manufacturer Narrative

If additional information should become available, a supplemental medwatch will be submitted accordingly.Correction: the manufacturer contact name has been updated as (b)(6).Contact phone number and email address have been updated accordingly.Investigation summary: the complaint device was discarded by the customer therefore the device is not available for a physical evaluation.This complaint is not confirmed.Without physically evaluating the device, a definite root cause cannot be determined.Review of the device history record indicated that this batch of product was processed without incident; therefore there is no evidence of manufacturing anomalies on the records reviewed.At this point in time, no corrective action is required, and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, depuy synthes (b)(4) 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.

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 dfa.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.Udi: (b)(4).

Event Description

Additional information received on 11/6/2018 stated that the case was completed using another shaver from different lot, there was an alternative product readily available.There was a 20-minute surgical delay.The type of procedure involved was shoulder arthroscopy.It was reported that the failure noted when the complaint process initiated when the shaver was being used to prepare for healix anchor insertion, it was noticed that there was metal debris seen in joint.

• 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: 7921297
• MDR Text Key: 122160401
• Report Number: 1221934-2018-54781
• 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,Followup,Followup
• Report Date: 08/31/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 283409
• Device Lot Number: M1802018
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2018
• Initial Date FDA Received: 09/30/2018
• Supplement Dates Manufacturer Received: 11/06/2018; 11/13/2018; 11/24/2018
• Supplement Dates FDA Received: 11/08/2018; 11/15/2018; 11/26/2018
• Patient Sequence Number: 1