MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM ASSEM UPPER PULL ROD; RECLAIM INSTRUMENTS : INSERTION DEVICES

Catalog Number 297500635

Device Problems Break (1069); Mechanical Jam (2983)

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

Event Date 08/03/2023

Event Type  malfunction  

Event Description

Device report from depuy synthes australia reports an event as follows: during a loan kit inspection, it was discovered that a reclaim assembly upper pull rod main body screw snapped in half with a jammed component.No other information is available.

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 the information is unknown, not available or does not apply, the section/field of the form is left blank.Device was used for treatment, not diagnosis.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: reclaim assembly upper pull rod main body screw snapped in half with jammed component.Unable to function optimally.The product damage documented in this pc has been identified during loan kit inspection, by the loan kit technician.The event date and alert date are the date that the inspection took place.There is no surgeon, procedure, or patient details available.The device associated with this report was returned to depuy synthes for evaluation.Visual investigation of the returned device found that the reclaim assem upper pull rod has broken from the dowel pin, the broken fragment has stuck inside of the reclaim assem upper pull rod.No other issues were identified.The observed condition of the device was consistent with a component failure that may have been caused by exposure to unintended forces, like off axis impaction, or applied forces before the device is fully threaded into its subcomponent(s).A dimensional inspection was not performed since it was not applicable to the complaint condition.A functional test was not performed since it was not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the reclaim assem upper pull rod would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error.There is no indication that a design or manufacturing issue has caused the reported 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.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary the device was not returned to depuy synthes for evaluation, however photo(s) were provided for review.Review of the provided photo(s) confirms that the device is broken but as per visuals jammed/seized condition cannot be conformed.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.

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.H10 additional narrative: added: d9.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: RECLAIM ASSEM UPPER PULL ROD
• Type of Device: RECLAIM INSTRUMENTS : INSERTION DEVICES
• 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 46581-0988 ; 3035526892
• MDR Report Key: 17484409
• MDR Text Key: 321258833
• Report Number: 1818910-2023-16326
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: 10603295156017
• UDI-Public: 10603295156017
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/08/2023

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: 297500635
• Device Lot Number: SO2003204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 08/29/2023; 09/19/2023; 09/26/2023
• Supplement Dates FDA Received: 08/29/2023; 09/20/2023; 09/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/16/2012
• 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