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

Catalog Number 6541-4-809

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

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

Event Date 08/15/2016

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

During the first surgery with the new triathlon instruments dr.(b)(6) told the sales rep that he has problems to connect the headless drill pins with the pin driver.He noticed that the connection between the drill pins and the pin driver has been loose and that the pin driver had a malfunction.

Manufacturer Narrative

An event regarding assembly issue involving a headless pin driver was reported.The event was confirmed.Method & results: device evaluation and results: the drive socket has light abrasions in various areas.The inner spring is dislodged from the seated area.The spring is twisted.Examination of the returned device with a material analysis engineer indicated that the damage observed on the spring is consistent with in-service use.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: the investigation concluded that because of the spring being twisted and not seated properly in its place within the headless pin driver, the connection with the drill pins was loose.The root cause was determined by an mar engineer who observed damage to the spring is consistent with in-service use.

Event Description

During the first surgery with the new triathlon instruments dr.(b)(6) told the sales rep that he has problems to connect the headless drill pins with the pin driver.He noticed that the connection between the drill pins and the pin driver has been loose and that the pin driver had a malfunction.

• Brand Name: HEADLESS PIN DRIVER
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• 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: cindy chuhinko ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5942617
• MDR Text Key: 54777608
• Report Number: 0002249697-2016-02895
• Device Sequence Number: 1
• Product Code: JWH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2017

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
• Device Operator: Health Professional
• Device Catalogue Number: 6541-4-809
• Device Lot Number: 23194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2016
• Initial Date FDA Received: 09/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 68