MAUDE Adverse Event Report: MAKO SURGICAL CORP. INSERTER- STRAIGHT SHELL; HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS, U

Catalog Number 112710

Device Problems Break (1069); Fracture (1260); Material Integrity Problem (2978)

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

Event Date 02/09/2016

Event Type  malfunction  

Manufacturer Narrative

An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Additional information has been requested and if received, will be provided in the supplemental report.

Event Description

Threads on the shell inserter straight is stripped and would not tighten.

Manufacturer Narrative

An event regarding thread damage involving an inserter was reported.The event was confirmed.Method & results: -device evaluation and results: visual inspection confirmed the reported event as the threads of the returned device were damaged.-medical records received and evaluation: no patient medical records were available for review.-device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other events for the lot referenced.Conclusion: the investigation concluded that the suspected cause of the problem was the deformation of threads occurs during impaction due to cup not fully seated on impaction shaft or during repositioning of the cup in the wound due to moment induced through the shaft.There was no surgical procedure associated with the reported event.This event meets the definition of preventive maintenance.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

Threads on the shell inserter straight is stripped and would not tighten.

• Brand Name: INSERTER- STRAIGHT SHELL
• Type of Device: HIP PROSTHESIS, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER, + ADDITIVE, POROUS, U
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: keyla colon ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 5481280
• MDR Text Key: 39749614
• Report Number: 0002249697-2016-00677
• Device Sequence Number: 1
• Product Code: OQG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122158
• 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: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 112710
• Device Lot Number: 120115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2013
• 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