MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*IMPACTOR STEM,ROTATOR; HIP INSTRUMENTS : IMPACTORS

Catalog Number	532029
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/13/2024
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 the inserter tip broke off.The pencil tip was bent.
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.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 : according to the information received, ¿it was reported that the inserter tip broke off.Pencil tip was bent¿.The product was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that s-rom*impactor stem,rotator has the distal tip broken off, fragment was not returned for evaluation.Additionally, the pin that attaches the clamp neck impactor to the main device was missing.The observed condition of the broken tip was consistent with a random component failure that may have been caused by exposure to unintended forces, such as, heavy usage, constant off-axis impactions and excessive force in a prying motion.A dimensional inspection and functional testing were not performed as it is not applicable to the complaint condition.The overall complaint was confirmed as the observed condition of the s-rom*impactor stem,rotator 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 : a manufacturing records evaluation (mre) was not performed as no lot number was retrieved for this device.

• Common Device Name: HIP INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• 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: 19404126
• Report Number: 1818910-2024-11578
• Device Sequence Number: 12477987
• Product Code: LXH
• UDI-Device Identifier: 10603295171607
• UDI-Public: 10603295171607
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/28/2024

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: 532029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/13/2024
• Supplement Date Received by Manufacturer: 06/11/2024; 07/08/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 06/13/2024; 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 58 YR
• Patient Sex: Female