MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME COMP DRIVER, X25; INSTRUMENT COMPRESSION

Catalog Number	286750083
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
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.H3, h4, h6 investigation summary 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 the device was broken from the tip.The broken fragments was not returned.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.The device exhibits surface wear consistent with normal use over time.Minor scratches, scuffs, and slight discoloration are present, which are typical signs of regular usage.There is no evidence to support the allegation of abnormal or excessive wear.A dimensional inspection for the device was not performed due to post manufacturing damage.The overall complaint was confirmed as the observed condition of the viper prime comp driver, x25 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.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.Dimensional inspection: n/a.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.
Additional Manufacturer Narrative
Product complaint (b)(4) h3, h6: the subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Investigation summary according to the information received, "upon compression, he stripped and broke the tip of the compressor t handle instrument.The tip was subsequently retrieved and removed.The case was completed with other instruments from expedium and viper prime" the product was returned to depuy synthes, and photos were provided for review.The photographs attached were reviewed, however they do not represent the reported complaint condition.Therefore, the investigation could not draw any conclusions about the reported event due to the insufficient evidence provided.The product was not returned to depuy synthes, however photos were provided for review.The photographs attached were reviewed, however the image attached doesn't show the complete device and no observations pertaining to the nature of the reported event could be identified.The overall complaint was unconfirmed as the photographs provided are not representative of the reported complaint condition.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 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 review of the receiving inspection (ri) viper prime comp driver, x25 was conducted identifying that lot number was km873415 released in one batch.Batch 1: lot qty of (b)(4) units were released on 19 dec 2018 with no discrepancies.Supplier: (b)(4) as a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review as a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.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 the surgeon was performing a mixed construment with expedium and viper prime.Upon compression, he stripped and broke the tip of the compressor "t" handle instrument.The tip was subsequently retrieved and removed.Fragments were generated and removed easily without additional intervention.The case was completed with other instruments from expedium and viper prime.The patient was not impacted, no delay was obtained.The procedure was successfully completed.There is no further information to add at this time.This report is for one (1)viper prime comp driver, x25.This is report 2 of 2 for complaint (b)(4).

• Brand Name: VIPER PRIME COMP DRIVER, X25
• Common Device Name: INSTRUMENT COMPRESSION
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 19569819
• Report Number: 1526439-2024-01686
• Device Sequence Number: 6305961
• Product Code: HWN
• UDI-Device Identifier: 10705034507736
• UDI-Public: (01)10705034507736(11)181219(10)KM873415
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Physician
• 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: 286750083
• Device Lot Number: KM873415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 07/24/2024
• Initial Report FDA Received Date: 06/19/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2018
• 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
• Concomitant Medical Products and Therapy/Usage Dates: X25 FINAL TIGHTENER.
• Patient Sex: Unknown