MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TIBIAL RESECTION BLOCK 7 DEG; KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES

Catalog Number 249256000

Device Problems Break (1069); Difficult to Remove (1528); Connection Problem (2900); Device-Device Incompatibility (2919); Mechanical Jam (2983); Physical Resistance/Sticking (4012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).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 steinmann pin (p/n: 869117p) was broken during the tka surgery of the patient¿s right knee joint on (b)(6), 2019.The surgeon inserted the steinmann pin with jacobs chuck.The steinmann pin was caught in the cutting block (p/n: 228705000) when the surgeon attempted to remove it from the hole for fixing the steinmann pin and it could not remove and it was broken.The surgery was completed without a surgical delay and there was no adverse consequence to the patient.No further information is available.

Manufacturer Narrative

Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.Product complaint # : (b)(4).Investigation summary: the devices were reviewed by bioengineering and a report was received stating it was unlikely that a manufacturing defect was present root cause attributed to the device being worn from normal use and servicing.Depuy synthese 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.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.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provision depuy synthesof 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.H10 additional narrative: product complaint (b)(4).Investigation summary : the devices were reviewed by bioengineering and a report was received stating it was unlikely that a manufacturing defect was present root cause attributed to the device being worn from normal use and servicing.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: TIBIAL RESECTION BLOCK 7 DEG
• Type of Device: KNEE INSTRUMENT : RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 8992325
• MDR Text Key: 185095410
• Report Number: 1818910-2019-103975
• Device Sequence Number: 1
• Product Code: HTZ
• UDI-Device Identifier: 10603295126003
• UDI-Public: 10603295126003
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 249256000
• Device Lot Number: AH0199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2019
• Date Manufacturer Received: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1