MAUDE Adverse Event Report: 1392 5.9MM STRYKER SHEATH 2 WAY -NS; RIGID ENDOSCOPE SHEATH

Model Number 281392

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2018

Event Type  malfunction  

Manufacturer Narrative

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).Investigation summary: despite multiple attempts made to the sales representative for the return of the complaint device, the device has not been received for evaluation.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.This complaint cannot be confirmed.No further information regarding the cause of the defect has been provided to help determine a definitive root cause for this failure.This complaint can be confirmed.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.This report is being filed as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.

Event Description

It was reported by the sales rep via phone that during a shoulder repair procedure the customer's 5.9 mm stryker sheath 2-way was leaking due to damaged o-rings.The procedure was able to be completed with the device with no harm to the patient or delays to the case.The sales rep was not present for the case therefore could not any further information.There was no delay in the surgical procedure.There was a spare device available for use to complete the surgery.There was patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.

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: according to the information received, it was reported that during a shoulder repair procedure the customer's 5.9mm stryker sheath 2-way is leaking due to damaged o-rings.Despite multiple attempts made to the sales representative for the return of the complaint device, the device has not been received for evaluation.No further information regarding the cause of the defect has been provided to help determine a root cause for this failure.This complaint cannot be confirmed.No further information regarding the cause of the defect has been provided to help determine a definitive root cause for this failure.According to attached memo referencing to sopro-comeg, as sopro-comeg gmbh maintained all manufacturing records in their files and no relation has been held with this company since september 2017, no manufacturing record evaluation can be performed for all lots manufactured by sopro-comeg gmbh.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: 1392 5.9MM STRYKER SHEATH 2 WAY -NS
• Type of Device: RIGID ENDOSCOPE SHEATH
• MDR Report Key: 9117750
• MDR Text Key: 160045612
• Report Number: 1221934-2019-58504
• Device Sequence Number: 1
• Product Code: HNX
• UDI-Device Identifier: 10886705016099
• UDI-Public: 10886705016099
• Combination Product (y/n): N
• PMA/PMN Number: K951702
• 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: 07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 281392
• Device Catalogue Number: 281392
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1