MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HEADLESS PIN EXTRACTOR; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO

Catalog Number 6541-4-804

Device Problems Connection Problem (2900); Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/04/2015

Event Type  malfunction  

Manufacturer Narrative

Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.

Event Description

It is reported by the nurse of the hospital that the headless pin extractor doesn't grasp the pins correctly.

Manufacturer Narrative

An event regarding pin extractor not holding pin involving a headless pin extractor was reported.The event was not confirmed.Method and results: device evaluation and results: visually the product appears to be in good condition.Medical records received and evaluation: not performed as no medical records were provided.There is no indication that patient factors contributed to the reported event.Device history review: review of the device history records indicated devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for lot and sterile lots.Conclusions: the returned pin extractor was functionally tested with a disposable fluted headless pin retrieved from stock, catalog: 7650-2038a lot: rd5e151.The stock pin was securely engaged with sawbone material placed in a vice.The pin extractor was able to grip the pin and extract it from the sawbone material without issue.The device is therefore concluded to be fully functional.The event could not be duplicated nor confirmed.

Event Description

It is reported by the nurse of the hospital that the headless pin extractor doesn't grasp the pins correctly.

• Brand Name: HEADLESS PIN EXTRACTOR
• 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: beverly lima ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5248456
• MDR Text Key: 32147679
• Report Number: 0002249697-2015-04013
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• PMA/PMN Number: K123486
• 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: 11/04/2015

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 Expiration Date: 05/31/2018
• Device Catalogue Number: 6541-4-804
• Device Lot Number: MC6L06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/04/2015
• Initial Date FDA Received: 11/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2013
• 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