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

Catalog Number 249067000

Device Problems Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

(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 a drill bit got stuck in the cutting block and damaged the inside of the block.The block is no longer usable because it has burs on the inside of the pinning holes that deter the drill bit from making it through the block.No pieces broke off.No pieces were left in the patient.The block needs to be replaced and is available for return.

Manufacturer Narrative

Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

A.Please clarify what you mean by damage? answer: as noted in the description, there were burs inside the drill hole.B.Please confirm if the instrument was used during surgery.If yes, was surgery time extended? answer: yes the instrument was used in surgery.C.What was the duration of the delay? answer: there was not a delay.D.Lot number of resection block 7 deg(249067000)? answer: lot number is unattainable.E.Please provide product code and lot number for unk drill? answer: nurse thee drill away.F.Please confirm if the unk drill is available for return? answer: no information available on drill bit.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary: no device was received for examination, therefore the reported event could not be confirmed.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: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.

• Brand Name: RESECTION BLOCK 7 DEG
• Type of Device: RESECTION BLOCKS/DEVICES
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 11445454
• MDR Text Key: 238639873
• Report Number: 1818910-2021-04725
• Device Sequence Number: 1
• Product Code: HTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: 249067000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/24/2021
• Initial Date FDA Received: 03/09/2021
• Supplement Dates Manufacturer Received: 03/09/2021; 04/06/2021
• Supplement Dates FDA Received: 03/15/2021; 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1