MAUDE Adverse Event Report: SYNTHES GMBH PROTECT SLEEVE 13 F/EXPERT R/AFN RETROGR; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	03.010.502
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
J&j medtech is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which j&j medtech has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, j&j medtech or its employees that the report constitutes an admission that the device, j&j medtech, 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.Additional narrative: investigation summary investigation summary the product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that protect sleeve 13 f/expert r/afn retrogr was received connected with the driver f/nut.The surface showed several scratches and nicks.This type of damage is consistent with other tools and hard edges coming in contact with the devices.A dimensional inspection for the protect sleeve 13 f/expert r/afn retrogr not performed due to post manufacturing damage.A functional test was performed to try to disassemble the devices, but it was not possible as they remained stuck.Per the expert r/afn stg surgical technique part number 03.010.502 protection sleeve 13.0 for expert r/afn, retrograde, is compatible with the part number 03.010.500 handle, with quick coupling and part number 03.010.507 multihole drill guide for protection sleeve 13.0, retrograde.In conclusion, the part number 03.045.033 driver f/nut is not compatible with the part number 03.010.502 protection sleeve 13.0 for expert r/afn, retrograde.The observed condition of the device is consistent with an incorrect use of the device due to incompatibility according to surgical technique.The overall complaint was confirmed as the observed condition of the protect sleeve 13 f/expert r/afn retrogr would contribute to the complained device issue.There is no indication that a design or manufacturing issue has caused the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.As part of j&j 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.Dimensional inspection: n/a device history part# 03.010.502 synthes lot# 187178 supplier lot# 187178 release to warehouse date: 04.Aug.2022.Supplier: (b)(4).No ncrs were generated during production.Device history batch null 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
The product damage documented 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.No further information can be obtained as the case was not reported by the customer.

• Brand Name: PROTECT SLEEVE 13 F/EXPERT R/AFN RETROGR
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22500346
• Report Number: 8030965-2025-07114
• Device Sequence Number: 8615120
• Product Code: HSB
• UDI-Device Identifier: 10886982069191
• UDI-Public: (01)10886982069191(10)187178
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K033618
• 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

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: 03.010.502
• Device Lot Number: 187178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2022
• 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