MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH PILOT WIRE; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 5901-1119

Device Problems Mechanical Problem (1384); Sticking (1597); Device Damaged by Another Device (2915)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

Doctor was performing a reunion on a shoulder.The doctor went to put k-wire through the base plate centering guide and it was stuck (jammed).The doctor had to change the process of the surgery.

Manufacturer Narrative

An event regarding the reunion pilot wire pilot wire getting "stuck" in the guide was reported.The event was confirmed.Method & results: device evaluation and results: the device showed signs of use.The devices were returned assembled and the pilot wire cannot be removed from the guide.The pilot wire appeared bent and had a fractured tip.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review: all devices accepted into final stock conformed to specification.Complaint history review: there has been one other event reported events for this lot id.Conclusions: the devices were returned assembled and the pilot wire cannot be removed from the guide.Therefore the shaft of the guide was unable to be examined.It is possible the root cause of the event to be debris found inside the shaft of the baseplate centering guide causing the devices to seize.If additional information becomes available, this investigation will be reopened.

Event Description

Doctor was performing a reunion on a shoulder.The doctor went to put k-wire through the base plate centering guide and it was stuck (jammed).The doctor had to change the process of the surgery.

• Brand Name: PILOT WIRE
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5613898
• MDR Text Key: 44454199
• Report Number: 0002249697-2016-01395
• 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,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 5901-1119
• Device Lot Number: SC16896
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2016
• 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