MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH BASEPLATE CENTERING GUIDE RIGHT; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Catalog Number 5901-1100

Device Problems Mechanical Problem (1384); Device Abrasion From Instrument Or Another Object (1387); Fitting Problem (2183); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/02/2016

Event Type  malfunction  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

It was reported that during a right reverse shoulder procedure, the pilot wire would not pass through the guide.Surgeon was able to complete the case without any delay or adverse consequence to patient.Upon further inspection of the guide after the case while rebuilding the kit, sale rep inspected and noticed that there are burrs on the inside of the pilot wire guide.

Manufacturer Narrative

An event regarding pilot wire not passing through the reunion rsa baseplate centering guide was reported.The event was confirmed.Method & results: device evaluation and results: the device showed signs of use.The device was examined with the aid of a stereo microscope.Debris was present inside the shaft of the device.It was determine the debris was likely from a pilot wire.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 have been no similar previous reported events for this lot id.Conclusions: the investigation determined the likely root cause of the event to be debris found inside the shaft of the baseplate centering guide.It was determined that there was rubbing of the k-wire causing a large amount of debris.Due to the debris build up the wire will not be able to pass through the guide.If additional information becomes available, this investigation will be reopened.

Event Description

It was reported that during a right reverse shoulder procedure, the pilot wire would not pass through the guide.Surgeon was able to complete the case without any delay or adverse consequence to patient.Upon further inspection of the guide after the case while rebuilding the kit, sale rep inspected and noticed that there are burrs on the inside of the pilot wire guide.

• Brand Name: BASEPLATE CENTERING GUIDE RIGHT
• 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: 5467601
• MDR Text Key: 39272352
• Report Number: 0002249697-2016-00610
• 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: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5901-1100
• Device Lot Number: P7S35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 85 YR