MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH HEADLESS PIN DRIVER; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	6541-4-809
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
Reporter stated that the rubber membrane inside this pindriver seems to be difficult to penetrate with a pin.Previous experience included having to rotate the pin 2 mm to get it in place.This pindriver it is hard to do so.The pin will only in 10% of the times get in the right position.Patient not affected, procedure completed successfully.
Additional Manufacturer Narrative
An event regarding user error involving a triathlon driver shaft was reported.The event was not confirmed.Method & results: device evaluation and results: as per visual inspection the spring inside the driver was in place and in good condition.Material analysis is not performed as this is not related to material integrity.A functional inspection was conducted on the returned device, headless pin driver, and headless pin 3" long triathlon.When inserting the headless pins into the driver a small twist of the pin locked into place.The pin is secure in the driver.The reported event of "the rubber membrane inside this pindriver seems to be difficult to penetrate with a pin" 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 no other event for the lot referenced.Conclusions: the event reported for during surgery it was observed that the rubber membrane inside the pin driver was difficult to penetrate with a pin.The event could not be confirmed nor the root cause determined on the basis of visual and functional inspection of the returned device.The spring inside the driver was in place and in good condition.A functional inspection was conducted on the returned device headless pin driver and headless pin 3" long triathlon.When inserting the headless pins into the driver a small twist of the pin locked into place.The pin is secure in the driver.The reported event of "the rubber membrane inside this pindriver seems to be difficult to penetrate with a pin" was not confirmed.If additional information becomes available, this investigation will be reopened.
Event or Problem Description
Reporter stated that the rubber membrane inside this pindriver seems to be difficult to penetrate with a pin.Previous experience included having to rotate the pin 2 mm to get it in place.This pindriver it is hard to do so.The pin will only in 10% of the times get in the right position.Patient not affected, procedure completed successfully.

• Brand Name: HEADLESS PIN DRIVER
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 6632073
• Report Number: 0002249697-2017-01810
• Device Sequence Number: 13592082
• Product Code: JWH
• UDI-Device Identifier: 07613327179293
• UDI-Public: (01)07613327179293(11)160114(10)24745
• Combination Product (Y/N): N
• PMA/510(K) Number: K143393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/18/2017

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
• Operator of Device: Health Professional
• Device Model Number: 6541-4-809
• Device Catalogue Number: 6541-4-809
• Device Lot Number: 24745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2017
• Initial Date Received by Manufacturer: 05/13/2017
• Supplement Date Received by Manufacturer: 09/19/2017
• Initial Report FDA Received Date: 06/09/2017
• Supplement Report FDA Received Date: 10/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other