MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HEADLESS PIN EXTRACTOR; INSTRUMENT

Catalog Number 6541-4-804

Device Problem Device Inoperable (1663)

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

Event Date 12/18/2014

Event Type  malfunction  

Event Description

It was reported that the pin extractor was not functional when the pin was extracted.

Manufacturer Narrative

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

Manufacturer Narrative

An event regarding a non functional device involving a triathlon headless pin extractor was reported.The event was not confirmed.Method & results: -device evaluation and results: the triathlon headless pin extractor was returned in good condition showing signs of normal wear and tear after being in the field for over seven years.There were no signs of abuse.The device was functionally tested using a triathlon headless pin.The extractor performed satisfactorily.There was no indication as to why the device was reported as non functional when the pin was extracted.-medical records received and evaluation: not performed because no patient clinical information was provided as there is no evidence to support the event was related to patient factors.-device history review: the reported device was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there has been 1 other event for the lot referenced.The headless pin extractor was reported as not being able to extract the pin.When the device was subsequently tested by stryker the reported failure could not be repeated/confirmed.Therefore, there is no lot commonality with the failure reported in the current event.This product and event will be monitored under quarterly trend request 491.Conclusions: the investigation concluded that the exact cause of the event could not be determined as the reported failure could not be duplicated/confirmed with the returned device.It was also concluded that there is no indication the event is related to a manufacturing issue.

Event Description

It was reported that the pin extractor was not functional when the pin was extracted.

• Brand Name: HEADLESS PIN EXTRACTOR
• 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: 4416597
• MDR Text Key: 15109723
• Report Number: 0002249697-2015-00073
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123486
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6541-4-804
• Device Lot Number: N2K16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/27/2007
• 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