MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 XTND 145 RSA IMPLANT INSERTER; DRILL GUIDES

Catalog Number 230784000

Device Problem Break (1069)

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

Event Date 02/21/2024

Event Type  malfunction  

Event Description

It was reported that after washing, the handle broke in half.There was no delay nor harm to the patient.Surgical delay was unknown.

Manufacturer Narrative

Product complaint (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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, or its employees that the report constitutes an admission that the product, 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 report, a follow-up report will be filed as appropriate.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : no device associated with this report was received for examination.An evaluation of the manufacturing record could not be performed as the required lot number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.If additional information is made available, the investigation will be updated as applicable.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.

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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary : it was reported that after washing, the handle broke in half.There was no delay nor harm to the patient.Surgical delay was unknown.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis revealed that xtnd 145 rsa implant inserter was broken at the middle section of the body inserter.The broken fragment was returned.No other issues were observed.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces, like impacting of the device before is fully seated.A dimensional inspection was not performed due to the post-manufacturing damage.The overall complaint was confirmed as the observed condition of the xtnd 145 rsa implant inserter would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, the potential cause is traced to unintended user error, and it has been determined that no corrective and/or preventative action is proposed.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: XTND 145 RSA IMPLANT INSERTER
• Type of Device: DRILL GUIDES
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581 ; 3035526892
• MDR Report Key: 18777059
• MDR Text Key: 336305028
• Report Number: 1818910-2024-04274
• Device Sequence Number: 1
• Product Code: PHX
• UDI-Device Identifier: 10603295518785
• UDI-Public: 10603295518785
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K192855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/26/2024

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: 230784000
• Device Lot Number: FE2081691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 03/01/2024; 04/01/2024; 04/11/2024
• Supplement Dates FDA Received: 03/05/2024; 04/02/2024; 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2020
• 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