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

Catalog Number	281392
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).This report is being filed from the etq complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Event or Problem Description
It was reported during an unknown procedure the 5.9 nn stryker sheath coupler was broken causing it now to hold the lens.The procedure was completed using a like device.There was no patient consequence or surgical delay.This report is 1 of 1 for (b)(4).
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Investigation summary: the device was received and evaluated.Visually inspection reveals that the metal coupler part of the sheath was broken off the device.The device was reviewed with the design and quality engineers for this product.They said that the laser weld that hold this part to the sheath is broken off.The weld marks are visible on the parts.They suspect that the device was dropped on a hard surface which caused this weld to break.This complaint can be confirmed.A review into the depuy synthes mitek complaints system revealed no other complaints of any type for the serial number of this device that was released to distribution.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.Udi:(b)(4).The serial number is not available.

• Brand Name: 1392 5.9MM STRYKER SHEATH 2 WAY -NS
• Common Device Name: RIGID ENDOSCOPE SHEATH
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8290838
• Report Number: 1221934-2018-53724
• Device Sequence Number: 11195987
• Product Code: HNX
• UDI-Device Identifier: 10886705016099
• UDI-Public: 10886705016099
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K951702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 281392
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2017
• Initial Date Received by Manufacturer: 05/08/2017
• Supplement Date Received by Manufacturer: 05/08/2017
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 02/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1