MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC EMPHASYS¿ SHELL/LINER IMP OFFS; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	200003002
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H11: additional narrative: the actual device has been returned and is currently pending evaluation.Once the device has been evaluated, a supplemental medwatch report will be sent accordingly.
Event or Problem Description
It was reported that the new offset shell/liner impactor device did not spin freely at the end that screwed into the cup.As a result, the cap could be placed on the inserter, but once implanted, it could not be removed with a screwdriver.The device had never been used.It was reported that another device was opened and used without issues.It was not reported if the device was used in surgery.It was not reported if there were any delays in a surgical procedure.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.
Additional Manufacturer Narrative
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, 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.Device was used for treatment, not diagnosis.If information is obtained that was not available for this medwatch, a supplemental medwatch report will be filed as appropriate.H11: additional narrative: h4: the device manufacture date has been added.
Additional Manufacturer Narrative
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, 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.H11: additional narrative: investigation summary the device was functionally and visually tested according to the diagnostic assessment.The device was visually inspected as received from the customer.It was found that the device passed visual inspection.The device failed following inspection criteria¿s during diagnostic assessment: 4.3.55 threaded fitting: fail the device was visually and functionally assessed and it was found that the device was unable to get secured.Therefore, the reported condition was confirmed.The instructions for use (ifu) states the following regarding the reported issue that was observed by the user or customer: remove the battery from the surgical impactor if attached.Insert the cylindrical part of the adapter into the end of the locking collar.Align the square part of the adapter with the locking collar to advance the instrument further.When the square part is able to advance into the impactor, push the adapter firmly into the locking collar.The locking collar is designed to automatically lock the adapter to the impactor upon a firm push (push to lock).Verify that the adapter is locked into the impactor with a visual inspection to verify that the end of the locking collar is aligned with the engraved line on the square part of the adapter or by pulling on the adapter to ensure a secure, locked connection.Device history review of the device history record(s) showed that there were no issues during the manufacture of this product which would contribute to this complaint condition.

• Brand Name: EMPHASYS¿ SHELL/LINER IMP OFFS
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• Manufacturer (Section G): TECHTRONIC INDUSTRIES MEDICAL; 1428 pearman dairy rd; anderson SC 29625
• Manufacturer Contact: kate karberg ; 4500 riverside drive; palm beach gardens, FL 33410 ; 3035526892
• MDR Report Key: 23086736
• Report Number: 1045834-2025-00545
• Device Sequence Number: 13223546
• Product Code: HWE
• UDI-Device Identifier: 07612334268778
• UDI-Public: (01)07612334268778(10)NW346167
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/18/2025

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: 200003002
• Device Lot Number: NW346167
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2025
• Supplement Date Received by Manufacturer: 10/22/2025; 11/12/2025
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 10/22/2025; 11/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Unknown