MAUDE Adverse Event Report: STRYKER GMBH PILOT WIRE; SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.

Catalog Number 5901-1119

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 06/28/2017

Event Type  malfunction  

Manufacturer Narrative

Once the investigation has been completed any additional information will be reported in a supplemental report.

Event Description

It was reported that the pilot wire outside box was opened, inside seal was not sterile.Proceeded to open another pilot wire already in the room.

Manufacturer Narrative

Product inquiry states the pilot wire [packaging] to be the subject product.No associated products were reported.A review of the device history records [dhr] revealed that the device was documented as faultless prior to distribution.The product [packaging] in question was received within its original packaging.A detailed inspection of the received outer pouch showed that the heat-sealed seam is completely missing at one side.According to drawing (b)(4) at both sides of the outer pouch a seal is required.Based on the above observations the root cause of the reported event is related to a process deviation during the sealing steps at the manufacturer, which was not detected during inspection.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the reported event for the subject product.This case has to be classified as a non-conformance and (b)(4) has been initiated for further root cause investigation.

Event Description

It was reported that the pilot wire outside box was opened, inside seal was not sterile.Proceeded to open another pilot wire already in the room.

• Brand Name: PILOT WIRE
• Type of Device: SHOULDER JOINT METAL/POLYMER SEMI-CONSTRAINED CEMENTED PROSTHESIS.
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; CH 2545
• Manufacturer Contact: rose haas ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6736633
• MDR Text Key: 80992362
• Report Number: 0008031020-2017-00448
• Device Sequence Number: 1
• Product Code: KWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 5901-1119
• Device Lot Number: SC18273K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/24/2017
• Supplement Dates Manufacturer Received: 10/23/2017
• Supplement Dates FDA Received: 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other