MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MODULAR CAPTURE - DISTAL RESECTION; INSTRUMENT

Catalog Number 6541-1-723

Device Problem Product Quality Problem (1506)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/28/2015

Event Type  malfunction  

Event Description

The customer, (b)(6), has reported that whilst inspecting their distal caprure assembly devices as part of ra 2014-169, they have found a non conforming device as detailed in the inspection bulletin.

Manufacturer Narrative

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

Manufacturer Narrative

A review of the device history records indicates that the reported devices were manufactured and accepted into final stock with no reported discrepancies.The complaint history review indicated that there have been similar events for the reported lot.Visual inspection on the returned device identified a fracture weld on one of the pins.A capa determined root cause as: in-process manufacturing tolerance change made at supplier location without formal change control process and adequate assessment of deliverables to be implemented.Notification to stryker also missed due to lack of change control.

Event Description

The customer, (b)(6), has reported that whilst inspecting their distal caprure assembly devices as part of ra 2014-169, they have found a non conforming device as detailed in the inspection bulletin.

• Brand Name: MODULAR CAPTURE - DISTAL RESECTION
• Type of Device: INSTRUMENT
• 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 navedo ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4795373
• MDR Text Key: 5829250
• Report Number: 0002249697-2015-01678
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-1-723
• Device Lot Number: ER6ED9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2249697-3/20/2015-004R
• Patient Sequence Number: 1
• Patient Outcome(s): Other