MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH TIBIAL INLAY IMPACTOR HEAD; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY

Catalog Number 160177

Device Problems Break (1069); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

If additional information is received, it will be provided in a supplemental report upon completion of the investigation.

Event Description

Blue foot attachment for the tibial impactor broke into two pieces.Pka case.

Manufacturer Narrative

Correction: e2/e3 health professional yes, physician surgeon.An event regarding crack/fracture involving a mako impactor was reported.The event was confirmed through visual inspection.Method & results: -device evaluation and results: the blue foot attachment for the tibial impactor was returned for evaluation.The device was returned fractured.Examination of the returned device with material analysis engineer indicated that the device fractured due to overload.No materials and manufacturing defects were observed on the surfaces examined.-medical records received and evaluation: not performed as no medical records were provided for review.-device history review: indicated that all devices were manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there has been one other similar event for the lot referenced.Conclusions: examination of the returned device with material analysis engineer indicated that the device fractured due to overload.No materials and manufacturing defects were observed on the surfaces examined.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.

Event Description

Blue foot attachment for the tibial impactor broke into two pieces.Pka case.

• Brand Name: TIBIAL INLAY IMPACTOR HEAD
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 7522663
• MDR Text Key: 108786985
• Report Number: 3005985723-2018-00301
• Device Sequence Number: 1
• Product Code: NPJ
• Combination Product (y/n): N
• PMA/PMN Number: K090763
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/20/2018

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: 10/31/2022
• Device Catalogue Number: 160177
• Device Lot Number: 12091017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 05/17/2018
• Supplement Dates Manufacturer Received: 06/21/2018
• Supplement Dates FDA Received: 07/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other