MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIBIAL RESECTION GUIDE RT; INSTRUMENT

Catalog Number 6541-2-700

Device Problems Break (1069); Sticking (1597); Material Integrity Problem (2978); Scratched Material (3020)

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

Event Date 03/12/2015

Event Type  malfunction  

Event Description

Reused fluted headless pin became stuck on tibial cutting block and staff, then broke pin inside triathlon pin driver.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding seizing of a fluted headless pin within a tibial resection guide was reported.The event was not confirmed.Method & results: device evaluation and results: a functional analysis could not confirm the event.A headless pin was able to pass through all 10 holes with no resistance.Medical records received and evaluation: not performed as patient factors did not contribute to the event.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 reported event could not be replicated.No product problem was found with the device.The pin associated with this event was not returned for investigation.No further investigation is required at this time.

Event Description

Reused fluted headless pin became stuck on tibial cutting block and staff then broke pin inside triathlon pin driver.

• Brand Name: TIBIAL RESECTION GUIDE RT
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 4671922
• MDR Text Key: 16460478
• Report Number: 0002249697-2015-01118
• 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: Other,Health Professional,health professional,oth
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-2-700
• Device Lot Number: RD8V030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2014
• 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: 71 YR