MAUDE Adverse Event Report: DEPUY FRANCE SAS - 3003895575 ROD FOR REAMING GUIDE HOLDER; ORTHOPEDIC INSTRUMENT HANDLE

Catalog Number	230774002
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).H6 component code: appropriate term/code not available (g07002) used to capture no findings available.Investigation summary = > an analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification 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.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.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.
Event or Problem Description
It was reported that this was a reverse total shoulder joint replacement for shoulder rotator cuff tear arthritis performed on (b)(6) 2024.The rod for reaming guide holder in question was inserted into the holder for reaming guides, and it was attached to the proximal reaming guide 12 mm.Then, it was inserted into the humerus.After reaming the proximal humerus, the surgeon attached the rod and the holder and attempted to remove the proximal reaming guide.Although it was connected to the proximal reaming guide by tightening the screws in the rod, it was not installed properly.It slipped, and the proximal reaming guide could not be removed.The rod tip was deformed and could not attached to the proximal reaming guide.The surgeon managed to extract the proximal reaming rod by using pliers and hitting it with a hammer.The surgeon proceeded to the next procedure, and all implants were inserted.There were no breakages and no metal fragments.The surgery was completed successfully within 30 minutes delay.There was no harm to the patient.No further information is available.
Additional 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: d4, h4 if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional 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.
Additional Manufacturer Narrative
Product complaint (b)(4).Investigation summary it was reported that this was a reverse total shoulder joint replacement for shoulder rotator cuff tear arthritis performed on (b)(6) 2024.The rod for reaming guide holder in question was inserted into the holder for reaming guides, and it was attached to the proximal reaming guide 12 mm.Then, it was inserted into the humerus.After reaming the proximal humerus, the surgeon attached the rod and the holder and attempted to remove the proximal reaming guide.Although it was connected to the proximal reaming guide by tightening the screws in the rod, it was not installed properly.It slipped, and the proximal reaming guide could not be removed.The rod tip was deformed and could not attached to the proximal reaming guide.The surgeon managed to extract the proximal reaming rod by using pliers and hitting it with a hammer.The surgeon proceeded to the next procedure, and all implants were inserted.The surgeon speculates that the installation of the rod and the holder at the time of initial insertion was lax and either deformed at time of insertion or was deformed from the beginning.There were no breakages and no metal fragments.The surgery was completed successfully within 30 minutes delay.There was no harm to the patient.No further information is available.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual inspection of the returned sample revealed that the rod for reaming guide holder appears slightly bent from the tip, and scratches are also observed on the tip.It is reasonable to conclude that these scratches may have occurred when it was connected to the proximal reaming guide, as it could have been ensembled incorrectly, causing the scratches and possibly the deformation at the tip along with the force that may have been exerted when using the device.The matting device was not returned and the jammed condition could not be replicated.However, due to damage found, the reported condition can be partially confirmed.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional test was unable to be performed due to the mating device did not return.Therefore the complaint could not be replicated.The overall complaint was confirmed as the observed condition of the rod for reaming guide holder would contribute to the complained device issue.Based on the investigation findings, the potential cause is traced to unintended use error and it has been determined that no corrective and/or preventative action is proposed.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.Corrected: h3.

• Brand Name: ROD FOR REAMING GUIDE HOLDER
• Common Device Name: ORTHOPEDIC INSTRUMENT HANDLE
• Manufacturer (Section D): DEPUY FRANCE SAS - 3003895575; 7 allee irene joliot-curie; b.p. 256; saint priest cedex 69801 ; FR 69801
• 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: 18787696
• Report Number: 1818910-2024-04398
• Device Sequence Number: 7757096
• Product Code: PHX
• UDI-Device Identifier: 10603295116134
• UDI-Public: 10603295116134
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/27/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 230774002
• Device Lot Number: 5250224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 03/11/2024; 03/11/2024; 04/09/2024; 07/08/2024
• Initial Report FDA Received Date: 02/27/2024
• Supplement Report FDA Received Date: 03/12/2024; 03/14/2024; 04/10/2024; 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown