MAUDE Adverse Event Report: MAKO SURGICAL CORP. FEMORAL TRIAL SLAPHAMMER; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM

Catalog Number 111140

Device Problems Crack (1135); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

Review of the product history records indicate products were manufactured and accepted into final stock with no reported relevant discrepancies.There have been two other similar events for the lot referenced.When completed, the evaluation summary will be submitted in a supplemental report.

Event Description

During trial extraction, threaded insert portion of the inserter snapped and was left in trial.Case type: pka.

Event Description

During trial extraction, threaded insert portion of the inserter snapped and was left in trial.Case type: pka.

Manufacturer Narrative

An event regarding crack/fracture involving a mako femoral trial slaphammer was reported.The event was confirmed through material analysis.Method & results: product evaluation and results: the slaphammer was not returned for analysis however the tip of the slaphammer was returned.Visual inspection was performed as part of the material analysis report (mar), dated 16 january 2019 which indicated: an sem image of the fracture surface of the slaphammer tip is shows transgranular cleavage and ductile dimple fracture morphologies were observed on approximately 70% of the fracture surface, indicating the slaphammer tip fractured in overload.Intergranular fracture morphologies were observed on approximately 30% of the fracture surface, additionally indicating the device fractured in overload.In addition one photograph was also provided for review.The photograph shows the instrument in a used condition.The tip of the instrument is fractured.The material analysis report revealed the tip of a slaphammer had fractured in the threaded hole of the trial.Mixed-mode and intergranular fracture morphologies were observed on the slaphammer, consistent with an overload condition.The intergranular fracture morphologies are potentially due to hydrogen embrittlement.The slaphammer was not returned for analysis.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.Product history review: indicated products were manufactured and accepted into final stock with no reported relevant discrepancies.Complaint history review: there have been two other similar events for the lot referenced.Pr 1806384 & pr 1711425 were raised for crack/fracture of a slaphammer.Conclusion: an event regarding crack/fracture involving a mako femoral trial slaphammer was reported.The slaphammer was not returned for analysis however the tip of the slaphammer was returned.Visual inspection was performed as part of the material analysis report (mar), dated 16 january 2019 which indicated: an sem image of the fracture surface of the slaphammer tip is shows transgranular cleavage and ductile dimple fracture morphologies were observed on approximately 70% of the fracture surface, indicating the slaphammer tip fractured in overload.Intergranular fracture morphologies were observed on approximately 30% of the fracture surface, additionally indicating the device fractured in overload.In addition one photograph was also provided for review.The photograph shows the instrument in a used condition.The tip of the instrument is fractured.The material analysis report revealed the tip of a slaphammer had fractured in the threaded hole of the trial.Mixed-mode and intergranular fracture morphologies were observed on the slaphammer, consistent with an overload condition.The intergranular fracture morphologies are potentially due to hydrogen embrittlement.The slaphammer was not returned for analysis.Based on the given information, no identifiable materials or manufacturing discrepancies 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.

• Brand Name: FEMORAL TRIAL SLAPHAMMER
• Type of Device: PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 8016237
• MDR Text Key: 125449271
• Report Number: 3005985723-2018-00619
• Device Sequence Number: 1
• Product Code: NPJ
• UDI-Device Identifier: 00848486002732
• UDI-Public: 00848486002732
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 111140
• Device Lot Number: 06060515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other