MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH VIPER PRIME CFXFN XTB 5X50MM S; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	186750450S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional procode: kwq, nkb.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.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 (b)(6) as follows: it was reported that on (b)(6) 2021 during an unknown procedure, the viper prime screw was unable to detach from the viper prime screwdriver.There was no patient consequence.There was a surgical delay of twenty (20) minutes.The procedure was successfully completed using a second screwdriver from the set.This report is for one (1) viper prime cfxfn xtb 5x50mm s.This is report 2 of 3 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.H10 additional narrative: d4 -lot number.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
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, h6: a product investigation was conducted.Visual inspection: the viper prime cfxfn xtb 5x50mm s (p/n: 186750450s lot no: tbacaw) was received at us cq in assembled condition with the viper prime nav shaft ass.Upon visual inspection at cq, no other damages were observed on the received devices.Functional test: the attempt to disassemble screw from the viper prime nav shaft assy failed.The device failed to function as intended.Dimensional inspection: the dimensional inspection was not performed due to post manufacturing damage.Document/ specification review: the relevant drawings reflecting the current and manufactured revisions were reviewed during the investigation.No design issues or discrepancies were noted during the investigation.Investigation conclusion: the complaint can be confirmed for the received device as it was unable to be disassembled from the viper prime navigation shaft assembly.No definitive root cause could be determined based on the provided information as whether the complaint condition happened due to failure of subcomponents of prime nav shaft assy or due to screw damage.No definitive root cause could be determined for the breakage of the screw tip.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.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 the dhr of product code: 186750450s, lot : tbacaw was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: "29-jun-2021 " qty: 349.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 PRIME CFXFN XTB 5X50MM S
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 12632134
• Report Number: 1526439-2021-02166
• Device Sequence Number: 4344238
• Product Code: KWP
• UDI-Device Identifier: 10705034529967
• UDI-Public: 10705034529967
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K173095
• 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,Followup
• Report Date (Section B): 09/16/2021

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 Model Number: 186750450S
• Device Catalogue Number: 186750450S
• Device Lot Number: TBACAW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 10/14/2021; 10/13/2021
• Initial Report FDA Received Date: 10/14/2021
• Supplement Report FDA Received Date: 11/08/2021; 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - ATTACHMENTS: VIPER PRIME; UNK - ATTACHMENTS: VIPER PRIME; UNK - HANDLES: VIPER PRIME; VIPER PRIME NAV SHAFT ASSY; UNK - ATTACHMENTS: VIPER PRIME; UNK - ATTACHMENTS: VIPER PRIME; UNK - HANDLES: VIPER PRIME; VIPER PRIME NAV SHAFT ASSY
• Patient Age: 72 YR
• Patient Sex: Female