MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OBT_CONCL_4.0,175_CW_STORZ; RIGID ENDOSCOPE OBTURATOR

Model Number 242585

Device Problem Material Deformation (2976)

Patient Problem Tissue Damage (2104)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 failure.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 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.

Event Description

It was reported by the affiliate in (b)(6) that during a knee arthroscopy procedure, it was observed that the obt_concl_4.0,175_cw_storz was too sharp.There was no delay the surgery.Another like device was used to complete the surgery successfully.There was damage to patient's cartilage.There were no fragments generated and there were no patient consequences.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.Additional narrative: 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 failure.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 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: OBT_CONCL_4.0,175_CW_STORZ
• Type of Device: RIGID ENDOSCOPE OBTURATOR
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin blanc 38; le locle CH-24 00; SZ CH-2400
• MDR Report Key: 10240600
• MDR Text Key: 199894067
• Report Number: 1221934-2020-01761
• 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: 07/01/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 242585
• Device Catalogue Number: 242585
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/07/2020
• Supplement Dates Manufacturer Received: 07/07/2020
• Supplement Dates FDA Received: 07/10/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention