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

Catalog Number 6541-1-723

Device Problems Break (1069); Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 06/15/2015

Event Type  malfunction  

Event Description

The sales rep has reported on behalf of the customer that one of the devices reported under ra 2014-069 has allegedly come apart during surgery.Further information has been requested from the sales rep.The customer has reported that there was no significant delay in surgery and that surgery was completed successfully.Additional information from the sales rep: following the alleged instrument break, the surgeon completed the surgery using another device from a different tray.Additional time added onto surgery of less than 10 minutes.What happened: the surgeon pinned the distal femoral cutting block to the bone as per recommended operative technique.The distal capture device was then clipped into place and the surgeon started to complete the resection with a standard reciprocating saw and the distal capture block fell apart into 5 pieces.All pieces were retrieved and are being sent back to the office.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding weld failure and pin dissociation of the modular capture was reported.The event was confirmed.Method & results: -device evaluation and results: a visual inspection confirmed the event.The cross pin was loose from the action trigger.-medical records received and evaluation: not performed as patient factors did not contribute to the event.-device history review: all devices accepted into final goods conformed to specification.-complaint history review: there have been similar reported events.Conclusions: the subject device has been identified as within the scope of nc and related capa where the cross pin located in the action trigger came loose during surgery.Further investigation identified a lack of press fit between the pin and action trigger.As a result, (b)(4) was implemented to raise awareness of the potential for weld disassociation through distribution of a product correction bulletin.Once conforming product is commercially available, stryker will replace all distal captures currently located in the field that exhibit the non-conformance.Replacement will occur on a rolling basis.Capa root cause: 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 sales rep has reported on behalf of the customer that one of the devices reported under (b)(4) has allegedly come apart during surgery.Further information has been requested from the sales rep.The customer has reported that there was no significant delay in surgery and that surgery was completed successfully.Additional information from the sales rep: following the alleged instrument break, the surgeon completed the surgery using another device from a different tray.Additional time added onto surgery of less than 10 minutes.What happened: the surgeon pinned the distal femoral cutting block to the bone as per recommended operative technique.The distal capture device was then clipped into place and the surgeon started to complete the resection with a standard reciprocating saw and the distal capture block fell apart into 5 pieces.All pieces were retrieved and are being sent back to the office.

• 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: 4903373
• MDR Text Key: 21126459
• Report Number: 0002249697-2015-02271
• 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,health professional,oth
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 06/16/2015

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 Catalogue Number: 6541-1-723
• Device Lot Number: ER7MA4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/16/2015
• Initial Date FDA Received: 07/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: 2249697-1/9/15-001R
• Patient Sequence Number: 1
• Patient Outcome(s): Other