MAUDE Adverse Event Report: DEPUY IRELAND - 3015516266 ATTUNE SPACER BLOCK 0 DEGREE

Catalog Number IGB0638

Device Problems Off-Label Use (1494); Device-Device Incompatibility (2919); Material Deformation (2976)

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

Event Date 06/12/2023

Event Type  malfunction  

Event Description

It was reported that during surgery but before the 0 degree mto spacer block was used, the surgeon noticed that the plastic shim would not attach properly because the circular spring (left side) was out of shape and blocking it.The surgeon used an artery clip to remove the spring and the plastic shim then attached properly.The surgery continued as normal, and the surgery time was not prolonged.

Manufacturer Narrative

Product complaint # (b)(4) 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : according to the information received, "[reason for complaint : during surgery but before the 0degree mto spacer block was used the surgeon noticed that the plastic shim would not attach properly because the circular spring (left side) was out of shape & blocking it.The surgeon used an artery clip to remove the spring and the plastic shim then attached properly.The surgery continued as normal and surgery time was not prolonged]" the product was not returned to depuy synthes, however photos were provided for review.See attachment (external re (b)(4) - additional information 1st request).It has been reported that this product was used in an off-label manor and not in accordance with depuy synthes ifu and surgical technique.Per the e-ifu for reusable instrument (0902-60-001 rev.B), during maintenance and inspection, instruments should be carefully inspected before each use to ensure that they are functional.Improperly functioning devices, (including bent or distorted devices) should not be used and be discarded.Although the photo investigation did not reveal any evidence to confirm the unable to assemble or deformed/bent allegation for the device, off label use of the device was confirmed based on "the surgeon used an artery clip to remove the spring." based on the investigation findings of off label use, no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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).A manufacturing records evaluation (mre) was not performed.

• Brand Name: ATTUNE SPACER BLOCK 0 DEGREE
• Type of Device: SPACER BLOCK
• Manufacturer (Section D): DEPUY IRELAND - 3015516266; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): LEEDS MFG & MATERIAL WAREHOUSE; st anthonys road; leeds LS11 8DT; UK LS11 8DT
• Manufacturer Contact: kate karberg ; 700 orthpaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 17173402
• MDR Text Key: 317725107
• Report Number: 1818910-2023-12711
• Device Sequence Number: 1
• Product Code: HSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IGB0638
• Device Lot Number: 9791017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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