MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 SP2 TIBIAL RADEL IMPACTOR; KNEE INSTRUMENT : IMPACTORS

Catalog Number 258111000

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/06/2018

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

It was reported that the white tibial block broke while impacting the tibial component.No surgical delay.

Manufacturer Narrative

No device associated with this report was received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.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: SP2 TIBIAL RADEL IMPACTOR
• Type of Device: KNEE INSTRUMENT : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910 ; 700 orthopaedic drive; warsaw IN 46582 0988
• Manufacturer Contact: chad gibson ; 700 orthopaedic drive; warsaw, IN 46582-0988 ; 5743725905
• MDR Report Key: 7268021
• MDR Text Key: 100042978
• Report Number: 1818910-2018-53354
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 10603295147916
• UDI-Public: 10603295147916
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 258111000
• Device Lot Number: SO2030479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2018
• Date Device Manufactured: 07/28/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1