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

Catalog Number 6541-4-804

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

Review of the product history records indicate the products were manufactured and accepted into final stock with no reported discrepancies.There has been one other event for the lot referenced.A supplemental report will be submitted upon completion of the investigation.

Event Description

The pin extractor does not hold the pins anymore.Replacement was available.

Manufacturer Narrative

An event regarding nonfunctional involving a triathlon extractor was reported.The event was not confirmed since the functional test confirmed that the device was fully functional.Method & results: device evaluation and results: visual inspection of the returned device was performed which noted that minor scratches were observed on the device.The returned triathlon extractor was functionally tested with a triathlon pin, part #: 6541-4-003 lot: ss173h12.The triathlon extractor accepted the triathlon pin and successfully gripped the pin with normal hand pressure.The triathlon extractor was confirmed to be fully functional.The reported event of "the pin extractor does not hold the pins anymore" was not confirmed.Medical records received and evaluation: not performed as no medical records were provided.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been 1 other event for the lot referenced.The event was not confirmed since the device was found to be functional.Conclusions: it was reported that the pin extractor does not hold the pins anymore.The event could not be confirmed as per the functional inspection of the returned device which indicated that, the triathlon extractor was confirmed to be fully functional.The triathlon extractor accepted the triathlon pin part #: 6541-4-003 lot: ss173h12 and successfully gripped the pin with normal hand pressure.No further investigation is required at this time.

Event Description

The pin extractor does not hold the pins anymore.Replacement was available.

• Brand Name: HEADLESS PIN EXTRACTOR
• Type of Device: EXTRACTOR
• 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: timothy rice ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 7086726
• MDR Text Key: 94410672
• Report Number: 0002249697-2017-03481
• Device Sequence Number: 1
• Product Code: HWB
• Combination Product (y/n): N
• PMA/PMN Number: K143393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/20/2018

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: 6541-4-804
• Device Lot Number: MC4W01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 12/06/2017
• Supplement Dates Manufacturer Received: 01/23/2018
• Supplement Dates FDA Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2010
• 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