MAUDE Adverse Event Report: DEPUY MITEK LLC US OBT_CONCL_4.0,175_CW_STORZ; RIGID ENDOSCOPE OBTURATOR

Model Number 242585

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

Event Date 06/23/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported by sales rep in (b)(6) that during a knee arthroscopy, an obt concl,2.4,75,cw_storz was too sharp and damaged the cartilage while entering the knee.No surgical delay was reported.The procedure was completed using the same device.There were no adverse patient consequences reported.No additional information could be 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.H10 additional narrative: investigation summary: the complaint device is not being returned, it was retained by the customer, therefore unavailable for a physical evaluation.With the information provided, and without the complaint device to evaluate, we cannot determine a root cause for the reported event.Further, no lot numbers were supplied which precludes conducting a dhr review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthese 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: OBT_CONCL_4.0,175_CW_STORZ
• Type of Device: RIGID ENDOSCOPE OBTURATOR
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10246441
• MDR Text Key: 199894384
• Report Number: 1221934-2020-01770
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 10886705028795
• UDI-Public: 10886705028795
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

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: 242585
• Device Catalogue Number: 242585
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/08/2020
• Supplement Dates Manufacturer Received: 07/16/2020
• Supplement Dates FDA Received: 07/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention