MAUDE Adverse Event Report: ZIMMER, INC. PATELLA REAMER BLADE WITH PILOT HOLE; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number 00597909551

Device Problem Difficult to Insert (1316)

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

Event Date 02/01/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported patella reamer blade did not fit the reamer guide properly.The procedure was completed with a reciprocating saw.No adverse events have been reported as a result of the malfunction.

Manufacturer Narrative

Cmp-(b)(4).The following report is submitted to relay additional and corrected information.(b)(4).Concomitant products: patella reamer surfacing guide with coating 51 mm diameter, lot#52319700, item#00512007151.Products was returned; the reported event is confirmed as the visual inspection identified scratches on outer diameter and near the slots.Dimensional inspection found that the inner and outer diameters were conforming to print specifications.Device history record  (dhr) was reviewed and no discrepancies relevant to the reported event were found.Review of the complaint history determined that no further action is required.From the analysis of the positioning of reamer blade in guide it was noted that, an angulation of 5 to 6 degrees of blade with reference to guide will cause the blade to strike in the guide.A definitive root cause cannot be determined by the information provided.No corrective actions, preventive actions, or field actions resulted after investigation of this event.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: PATELLA REAMER BLADE WITH PILOT HOLE
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6388870
• MDR Text Key: 69408853
• Report Number: 0001822565-2017-01594
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 00597909551
• Device Lot Number: 63538896
• Other Device ID Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2017
• Initial Date FDA Received: 03/08/2017
• Supplement Dates Manufacturer Received: 10/12/2017
• Supplement Dates FDA Received: 10/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/19/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 62 YR