MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 SUMMIT STANDARD IMP. INSERTER; HIP INSTRUMENTS : IMPACTORS

Catalog Number	257005100
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional 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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during a procedure he instrument corail amt neck seg 135d std and broach corail size 14, got stuck together when trialing and cannot be separated.The instruments summit standard imp.Inserter and quickset taper hex scdr rigid has a worn out threads/tip which tends for the implant to get stuck as well.Another set was opened to use.There was no patient consequence.There was no additional time required only was when opening for another set.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received, "the instruments summit standard imp.Inserter and quickset taper hex scdr rigid has a worn out threads/tip which tends for the implant to get stuck as well." the product was not returned to medtech orthopaedics, however photos were provided for review.See attachment " re_ (b)(6) broken instruments (product ref_ l20431_ l20414_ 257005100 & 227447000)".The photo investigation of " 257005100, summit standard imp.Inserter" can not revealed the reported condition.As, the evidence provided was not sufficient to confirm the reported event of jammed or seized.Functionality issues cannot be evaluated through photo investigation.But from the provided evidence we can observed that the tip of the device has bent or deformed.Potential cause can be attributed to unintended use error by use of excessive force in a prying motion and overload of the material.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the observed condition of the summit standard imp.Inserter would not contribute to the complained device issue.Based on the investigation findings, 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 complaint condition.As part of medtech orthopaedics 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: SUMMIT STANDARD IMP. INSERTER
• Common Device Name: HIP INSTRUMENTS : IMPACTORS
• Manufacturer (Section D): DEPUY IRELAND - 9616671; loughbeg ringaskiddy co.; cork ; EI
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22054865
• Report Number: 1818910-2025-08209
• Device Sequence Number: 7175571
• Product Code: HWR
• UDI-Device Identifier: 10603295143215
• UDI-Public: (01)10603295143215(10)SO2010288
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 257005100
• Device Lot Number: SO2010288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/29/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 05/20/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2013
• 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