MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH MIS 4:1 MODULAR CAPTURE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 6541-5-806

Device Problems Break (1069); Sticking (1597); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

It was noted that the device was retained by the hospital and therefore is not available for evaluation.Additional information has been requested and if received, will be provided in the supplemental report upon completion of the investigation.

Event Description

While drilling tibial baseplate trail, 1/8 drill with stop broke.No adverse consequences to the patient, surgery performed as normal.Also modular 4 in 1 capture getting stuck on cutting block.Not easy to remove.Information submitted was everything from both surgeon and hospital- no further details.

Manufacturer Narrative

Reported event: an event regarding seizing involving a triathlon cutting block was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: not performed as patient factors did not contribute to the event.-device history review: a device history review confirmed all devices were manufactured and accepted into finished goods with no reported discrepancies.-complaint history review: a complaint history review confirmed no similar events for the reported lot.Conclusions: the event could not be confirmed nor the root cause determined because the instrument was not returned for evaluation and insufficient information was provided.If the instrument and/or additional information are received, this investigation will be reopened and re-evaluated.

Event Description

While drilling tibial baseplate trail, 1/8 drill with stop broke.No adverse consequences to the patient, surgery performed as normal.Also modular 4 in 1 capture getting stuck on cutting block.Not easy to remove.Information submitted was everything from both surgeon & hospital- no further details.

• Brand Name: MIS 4:1 MODULAR CAPTURE
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
• 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: jadwiga degrado ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 6080646
• MDR Text Key: 59559909
• Report Number: 0002249697-2016-03469
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-5-806
• Device Lot Number: SB9M44
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2014
• 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: 63 YR
• Patient Weight: 104