MAUDE Adverse Event Report: DEPUY MITEK LLC US EXTERNAL STERILIZATION CASE LID; INSTRUMENT TRAY

Model Number 215459

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2020

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.Udi: (b)(4).The lot number is unknown.

Event Description

It was reported by the sales rep via phone that during a shoulder scope the delamination of two of the sterilization case lids was coming off.Another device was used to complete the procedure.No patient consequences or surgical delay reported.The device(s) is/are available to be returned for evaluation.Additional information reported by the affiliate stated the lot number is unknown because it is not on the over.

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 provided, it was reported that during a shoulder scope the delamination of two of the sterilization case lids was coming off.Multiple attempts have been made to obtain further information; however, it has not been made available and no product has been returned.Therefore, unavailable for a physical evaluation.Since the complaint device was not returned, we cannot determine a root cause for the reported failure.If the device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Given that no lot number was provided, a manufacturing record evaluation (mre) review cannot be performed.If the lot number becomes available, the mre review will be performed.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.

• Brand Name: EXTERNAL STERILIZATION CASE LID
• Type of Device: INSTRUMENT TRAY
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10225026
• MDR Text Key: 198921781
• Report Number: 1221934-2020-01738
• Device Sequence Number: 1
• Product Code: FSM
• UDI-Device Identifier: 10886705005123
• UDI-Public: 10886705005123
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 06/19/2020

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 Model Number: 215459
• Device Catalogue Number: 215459
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 07/02/2020
• Supplement Dates Manufacturer Received: 08/06/2020
• Supplement Dates FDA Received: 08/07/2020
• Patient Sequence Number: 1