HIGH FLOW SHEATH, STRYKER 5.9 281392

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-07-26 for HIGH FLOW SHEATH, STRYKER 5.9 281392 manufactured by Depuy Mitek Llc Us.

Event Text Entries

[115402496] If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Investigation summary : the complaint device was received and evaluated. Visual observations reveal that all components on the returned sheath are intact and there are no loose or broken parts. We cannot confirm this complaint at this point. A batch record review has been conducted and our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem. Further, a review into the depuy mitek complaints system revealed no other complaints of any type for this lot of devices that were released to distribution in 2010. This device is 4 years old and probably has seen heavy use. Based on the overall complaint rate for this failure mode, at this time, no further actions are warranted. However, depuy 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. Device history lot : a check of the manufacturing finished goods records for the reported batch number revealed no anomalies relating to the reported incident. There were devices released for distribution in october, 2010. There were no anomalies or discrepancies in the manufacture of this lot. This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Patient Sequence No: 1, Text Type: N, H10

[115402497] The sales rep reported that during a shoulder procedure that the customer's high flow sheath, stryker 5. 9, broke where it attaches to the tube outside of the patient. The sales rep reported that nothing fell inside the patient. The surgeon completed the procedure with another like device and with no patient consequence. There was a 15 minute delay. The sales rep could not provide the lot number but reported the device was over two years old, worn and had seen heavy use.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1221934-2018-54216
• MDR Report Key: 7723797
• Report Source: OTHER
• Date Received: 2018-07-26
• Date of Report: 2014-11-03
• Date of Event: 2014-11-03
• Date Mfgr Received: 2014-11-03
• Device Manufacturer Date: 2010-10-01
• Date Added to Maude: 2018-07-26
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 0
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MRS. JENNIFER LAWRENCE
• Manufacturer Street: 325 PARAMOUNT DRIVE
• Manufacturer City: RAYNHAM MA 02767
• Manufacturer Country: US
• Manufacturer Postal: 02767
• Manufacturer Phone: 5088808100
• Manufacturer G1: DEPUY MITEK LLC US
• Manufacturer Street: 325 PARAMOUNT DRIVE
• Manufacturer City: RAYNHAM MA 02767
• Manufacturer Country: US
• Manufacturer Postal Code: 02767
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 0

• Brand Name: HIGH FLOW SHEATH, STRYKER 5.9
• Generic Name: RIGID ENDOSCOPE SHEATH
• Product Code: HRX
• Date Received: 2018-07-26
• Returned To Mfg: 2014-11-21
• Catalog Number: 281392
• Lot Number: 45458024
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: DEPUY MITEK LLC US
• Manufacturer Address: 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767

Device Sequence Number: 1

• Brand Name: HIGH FLOW SHEATH, STRYKER 5.9
• Generic Name: RIGID ENDOSCOPE SHEATH
• Product Code: HNX
• Date Received: 2018-07-26
• Returned To Mfg: 2014-11-21
• Catalog Number: 281392
• Lot Number: 45458024
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Eval'ed by Mfgr: Y
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: DEPUY MITEK LLC US
• Manufacturer Address: 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-07-26