MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US IN-CONDL CHISEL 8X10X7 3/4 IN; KNEE INSTRUMENT : CUTTING INSTRUMENTS

Catalog Number	242101000
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Device is an instrument and is not implanted/explanted.Investigation summary: examination of the returned device confirmed the reported event.Additionally, the tip of the device was identified as chipped.The complaint consisted of (1) 242101000 in-condl chisel 8x10x7 3/4 in, lot number s02015050 examination of the submitted in-condl chisel 8x10x7 3/4 in confirmed the device was worn.Additionally, the tip of the device was identified as chipped.The broken off fragment was not returned.The initial reporting stated no pieces of the device were left in the patient.The radel handle has scratches and discoloration expected with normal use of the instruments.Wear marks were also present.A complaint database search against product code 242101000 found similar reported events.Additional reported event was investigated and found the tips of the chisels were loaded beyond the material limit resulting in mixed mode ductile and brittle overload of the material and fracture.The root cause is attributed to user error/technique.The tip of the chisel was loaded beyond the material limit resulting in mixed mode ductile and brittle overload of the material and fracture.No evidence was found indicating product error was a contributing factor to the device breakage and the need for corrective action was not indicated.Monitor complaints.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
Event or Problem Description
It was reported that the tips of the instruments were worn and need replacing.There were no broken parts, no broken pieces and no instruments left in the patient.Examination of the returned device confirmed the reported event.Additionally, the tip of the device was identified as chipped.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint #: (b)(4).Investigation summary: examination of the returned device confirmed the reported event.Additionally, the tip of the device was identified as chipped.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.Device history lot: null.Device history batch: null.Device history review: null.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: IN-CONDL CHISEL 8X10X7 3/4 IN
• Common Device Name: KNEE INSTRUMENT : CUTTING INSTRUMENTS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8432349
• Report Number: 1818910-2019-87742
• Device Sequence Number: 13868995
• Product Code: FZO
• UDI-Device Identifier: 10603295122715
• UDI-Public: 10603295122715
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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: 242101000
• Device Lot Number: S02015050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2019
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 03/26/2019
• Initial Report FDA Received Date: 03/19/2019
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1