MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER 2 SYSTEM ROD HOLDER, ADVANCED; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	286735200
Medical Device Problem Codes	Use of Device Problem (1670); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
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: d9: complainant part is not expected to be returned for manufacturer review/investigation.E3: reporter is a j&j employee.H3, h4, h6: without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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
Device report from synthes reports an event in colombia as follows: it was reported that on (b)(6) 2023, at the time of assembling the bar in the bar holder, it was evident that it needed the internal screw that tightens the bar; however, the four additional bar holders in the equipment did not have the internal screw, and therefore they could not be used.The surgeon sought a solution to be able to place the bar, and was able to complete the surgery in an appropriate way.The procedure was completed successfully with a delay of one hour.This report involves one viper 2 system rod holder, advanced.This is report 5 of 5 for (b)(4).
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.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device.The photo investigation revealed, that the locking bolt of the viper2 rod holder advanced is missing.Without locking bolt, the device functionally cannot be perform correctly.Therefore, the reported allegation can be confirmed.A potential cause cannot be established with the provided information, due to be a multifactorial issue.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed, for viper2 rod holder advanced.There is no indication, that a design or manufacturing issue has caused the complaint condition.And hence, the root cause cannot be determined.Based on the investigation findings.It has been determined, that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.As part of depuy synthes quality process, all devices are manufactured, inspected and released to approved specifications.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.

• Brand Name: VIPER 2 SYSTEM ROD HOLDER, ADVANCED
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• 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: 17610264
• Report Number: 1526439-2023-01531
• Device Sequence Number: 15308921
• Product Code: LXH
• UDI-Device Identifier: 10705034214542
• UDI-Public: (01)10705034214542
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: 286735200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: EXP PEEK ROD HOLDER ANGLED; VIPER2 ROD HOLDER, ADVANCED; VIPER2 ROD HOLDER, ANGLED; VIPER2 ROD HOLDER, ANGLED
• Patient Sex: Unknown