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); Detachment Of Device Component (1104); Degraded (1153); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/02/2016

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted upon completion of the investigation.

Event Description

It was reported that the threads on a pst 58 mm cup came off during impaction.Shell impactor used to try and recover cup and threads got damaged.

Manufacturer Narrative

An event regarding damaged threads involving a mako inserter was reported.The event was confirmed.Visual inspection confirmed the reported event as the threads of the returned device were damaged.A material analysis report concluded.Damage was observed on the threads of the inserter.The damage was consistent with contact against a hard object.No material or manufacturing defects were observed on the surfaces examined.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 there have been two other events for the lot referenced.The investigation concluded that the damage on the threads are consistent with contact against a hard object.No material or manufacturing defects were observed on the surfaces examined.If additional information become available, this investigation will be reopened.

Event Description

It was reported that the threads on a pst 58 mm cup came off during impaction.Shell impactor used to try and recover cup and threads got damaged.

• 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: 5761058
• MDR Text Key: 49244386
• Report Number: 3005985723-2016-00207
• Device Sequence Number: 1
• Product Code: OQG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112802
• 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: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2020
• Device Catalogue Number: 112710
• Device Lot Number: 120266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/17/2015
• 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
• Patient Age: 59 YR
• Patient Weight: 127