MAUDE Adverse Event Report: MAKO SURGICAL CORP. RIO®SHELL IMPACT-OFFSET-TRIDENT PST; STEREOTAXIC DEVICE, ROBOTICS

Catalog Number	209830
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
Event or Problem Description
It was noticed the end of the offset impactor handle was broken during impaction of the cup.The impactor was already broken before the case, but (b)(6) still decided to use it.Case type: tha.
Additional Manufacturer Narrative
It was reported that the end of the offset impactor handle was broken during impaction of the cup.The impactor was already broken before the case, but dr.(b)(6) still decided to use it.Product evaluation and results: visual inspection: the 209830 rio shell impact-offset-trident pst (lot 32884) shows wear and tear (dings and scratches) on the device shaft and body.The end of the shaft (interface for the 206270 shell impaction platform) was broken off.A pictures of the shaft is attached.Functional inspection: the 206270 shell impaction platform could not go onto the shaft of the 209830 rio shell impact-offset-trident pst (lot 32884).The failure mode ¿end of the offset impactor handle was broken¿ was confirmed.Dimensional inspection: n/a - not performed.Material analysis: n/a - not performed.Product history review: review of the product history records indicate (b)(4) were manufactured under lot no 32884 and accepted into final stock on 07/07/2016.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209830, lot number 32884, shows 08 additional complaints related to the failure in this investigation.Conclusions: the failure is confirmed via visual inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
Event or Problem Description
It was noticed the the end of the offset impactor handle was broken during impaction of the cup.The impactor was already broken before the case, but dr.(b)(6) still decided to use it.Case type: tha.

• Brand Name: RIO®SHELL IMPACT-OFFSET-TRIDENT PST
• Common Device Name: STEREOTAXIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• MDR Report Key: 9007943
• Report Number: 3005985723-2019-00671
• Device Sequence Number: 19427394
• Product Code: OLO
• UDI-Device Identifier: 00848486030285
• UDI-Public: 00848486030285
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K141989
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

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
• Operator of Device: Health Professional
• Device Catalogue Number: 209830
• Device Lot Number: 32884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 11/26/2019
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 64 YR
• Patient Weight: 95