MAUDE Adverse Event Report: SYNTHES GMBH SPINDLE NUT; APPARATUS, TRACTION, NON-POWERED

Catalog Number	394.42
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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.H10 additional narrative: 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 the screw was found broken form the head.The broken fragment was returned.A dimensional inspection was not performed due to the post-manufacturing damage.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.The overall complaint was confirmed as the observed condition of the unk - screws: trauma would 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 reported complaint condition.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and device history lot the device lot number is unknown, therefore a device history review could not be performed.If more information become available, the record will be re-assessed.Device was used for treatment, not diagnosis.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 on october 3,2024 the large distractor spindle nut was stuck on threaded spindle.The threaded spindle appears to be made of a different material compared to the other large distractor sets.Procedure was completed successfully.There was no patient consequences.
Event or Problem Description
Additional information was received and stated that the product 14.0mm threaded spindle 480mm (394.40) was stuck & would not move when connected to the product spindle nut (394.42).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, 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.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, 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.H11 additional narrative: h3, h4, h6: the product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device revealed that the spindle nut showed slight signs of damage of stripped on the internal thread.This condition could have been caused by interaction with the mating device, which has damage in the threaded area, preventing it from being fully threaded.Therefore, the reported condition can be confirmed.The observed condition was identified as an end-of-life indicator, damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific ifu for information related to end of life, reprocessing instructions, and inspection procedures.A dimensional inspection was not performed as it is not applicable to the complaint condition.A functional evaluation was performed using the nut and the mating device, which threaded correctly initially, however, upon reaching the middle of the device, it got stuck and could not thread further, precisely in the area where the thread is damaged.Therefore, the reported condition could be replicated.The overall complaint was confirmed as the observed condition of the spindle nut would have contributed to the complained issue.Based on the investigation findings, the potential cause is traced to end of life, and it has been determined that no corrective and/or preventative action is required.There is no indication that a design or manufacturing issue has caused the reported complaint condition.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.Device history review (dhr): the lot 5361p99 doesn't exist.The dhr review cannot be performed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: SPINDLE NUT
• Common Device Name: APPARATUS, TRACTION, NON-POWERED
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): MONUMENT; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20418795
• Report Number: 8030965-2024-12700
• Device Sequence Number: 8613045
• Product Code: HST
• UDI-Device Identifier: 10886982199706
• UDI-Public: (01)10886982199706(10)5361P99
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup
• Report Date (Section B): 10/10/2024

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: 394.42
• Device Lot Number: 5361P99
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2024
• Supplement Date Received by Manufacturer: 10/16/2024; 11/25/2024; 02/27/2025
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 10/22/2024; 12/02/2024; 02/28/2025
• 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 Sex: Unknown