MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH MIS SINGLE INNER SETSCW; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	186770345S
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional product code: kwp, kwq.Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 (b)(6) reports an event as follows: it was reported on (b)(6) 2020 that the patient underwent for a tlif (transforaminal lumbar interbody fusion) in the lumbar spine treating degenerative disease.During the procedure, the surgeon was not able to apply torque on screws (unk) and setscrews (unk) during final fixation.The procedure was completed with replacements less than 30-minute surgical delay.The patient outcome was unknown.Concomitant device reported: unknown torque device (part# unknown, lot# unknown, quantity unknown).This report is for (1) viper prime cfx xtab 7x45mm ti.This report is 4 of 5 for (b)(4).
Additional Manufacturer Narrative
Depuy synthese is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthese has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthese or its employees that the report constitutes an admission that the device, depuy synthese, or its employees caused or contributed to the potential event described in this report.D2: additional product code kwp;kwq;mnh;mni;osh.H3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.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.H10 additional narrative: h3, h6: investigation summary: the product was returned to us cq for evaluation.The us cq team conducted a visual inspection of the returned device.Visual analysis of the returned sample revealed that the internal drive feature was deformed in the mis single inner setscw implant.The dimensional inspection was not performed due to the post-manufacturing damage.The functional test cannot be performed due to the device's internal drive feature damage and the mating screwdriver was not returned for the evaluation.The deformed condition of the internal drive feature was consistent with a random component failure that may have been caused by exposure to unintended/overt forces.As part of depuy spine¿s quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed as visual inspection of the received device identified deformation of the set-screws internal drive feature.While no definitive root cause could be determined, it is probable that the observed deformation caused the alleged functional issue.There was no indication that a design or manufacturing issue contributed to the complaint.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.Drawing/specifications reviewed? the related drawing are reflecting the current and manufactured revisions were reviewed.Device history lot: the dhr of product code: 186715000, lot : 275794, was electronically reviewed and no non-conformances were observed during the manufacturing process.The product was released on: 10.03.2020 qty: (b)(4).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: MIS SINGLE INNER SETSCW
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• MDR Report Key: 11076995
• Report Number: 1526439-2020-02483
• Device Sequence Number: 11590837
• Product Code: NKB
• UDI-Device Identifier: 10705034530185
• UDI-Public: (01)10705034530185
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/30/2020

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: 186770345S
• Device Catalogue Number: 186715000
• Device Lot Number: 275794
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 01/11/2021; 01/29/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 01/15/2021; 02/08/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VIPER PRIME CFX XTAB 7X45MM TI; VIPER PRIME CFX XTAB 7X45MM TI; VIPER PRIME CFX XTAB 7X45MM TI; VIPER PRIME CFX XTAB 7X45MM TI; VIPER PRIME CFX XTAB 7X45MM TI.; VIPER PRIME CFX XTAB 7X45MM TI.; VIPER PRIME CFX XTAB 7X45MM TI.; VIPER PRIME CFX XTAB 7X45MM TI.