MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH ONLAY INSERT EXTRACTOR; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 160430

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2016

Event Type  malfunction  

Manufacturer Narrative

When completed, the investigation results will be submitted in a supplemental report.

Event Description

During removal of mako pka poly trial, the poly extractor tool would not fit in the poly removal holes, as the pegs on the tool were bent.

Manufacturer Narrative

Reported event: an event regarding damage involving a onlay insert extractor was reported.The event was confirmed.Method & results: device evaluation and results: visual inspection of the onlay insert extractor with the log visible found the left pin appears to be bent outward.The device is dimensionally out of specification.Medical records received and evaluation: not performed as there were no medical records.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 the onlay insert extractor is out of specification which will cause the device to not work as intended.A review of the inspection record indicated 8 were reviewed and passed inspection for the pin degree feature.The database was reviewed for similar events and many of the complaints were reported as difficult to use which possibly led to the damaged pins.There are clear signs of misuse over time due to rust in the leaf springs which resulted in the device becoming unusable.

Event Description

During removal of mako pka poly trial, the poly extractor tool would not fit in the poly removal holes, as the pegs on the tool were bent.

• Brand Name: ONLAY INSERT EXTRACTOR
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: sandra spokane ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5585250
• MDR Text Key: 42946237
• Report Number: 3005985723-2016-00124
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 160430
• Device Lot Number: 26080913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2013
• 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