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

Catalog Number	6541-4-809
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Review of the product history records indicates the products were manufactured and accepted into final stock with no reported discrepancies.There have been no other similar events for the lot referenced.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The customer reported that it seems hard to get the pin into 2 headless drivers.It seems like the rubber membrane inside is too hard and you have to push and turn quite hard to penetrate the membrane.
Additional Manufacturer Narrative
An event regarding assembly issue involving a headless pin driver was reported.The event was not confirmed.Device evaluation and results: the drive socket has light abrasions in various areas.Examination of the returned device with a material analysis engineer indicated that the damage consistent with in-service use observed on driver.Medical records received and evaluation: not performed as medical records were not received.Device history review: review of the device history records indicates devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events for this lot.Conclusions: it is reported that it was hard to get the pin into 2 headless drivers.The event could not be confirmed nor the root cause determined however visual inspection of returned device indicated that the drive socket has light abrasions in various areas.Examination of the returned device with a material analysis engineer indicated that the damage consistent with in-service use observed on driver.If additional information are received, this investigation will be reopened and re-evaluated.
Event or Problem Description
The customer reported that it seems hard to get the pin into 2 headless drivers.It seems like the rubber membrane inside is too hard and you have to push and turn quite hard to penetrate the membrane.

• 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: 6902631
• Report Number: 0002249697-2017-02875
• Device Sequence Number: 1183169
• Product Code: JWH
• UDI-Device Identifier: 07613327179293
• UDI-Public: 07613327179293
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2017

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 Catalogue Number: 6541-4-809
• Device Lot Number: 31019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2017
• Initial Date Received by Manufacturer: 08/31/2017
• Supplement Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 09/28/2017
• Supplement Report FDA Received Date: 11/22/2017
• 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