MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH SI POLYAXL EXT TAB 7 X 45MM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Model Number	179732745
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.The investigation could not be completed; no conclusion could be drawn, as no product was received.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 during a tlif (transforaminal lumbar interbody fusion) treating asd (adult spinal deformity) on (b)(6) 2020, the screw was not able to be connected to a screwdriver.The procedure was completed without surgical delay.Patient is noted as stable.Concomitant device reported: unknown screwdriver (part#: unknown, lot#: unknown, quantity unknown).This is report 1 of 1 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.H3, h4, h6: a device history record (dhr) review was conducted: the dhr of product code 179732745, lot 256559, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on september 21, 2019.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.
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.B5: updated event description.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.
Event or Problem Description
This complaint involves two (2) devices.
Additional Manufacturer Narrative
H10 additional narrative: h3, h4, h6 investigation summary visual inspection: the si polyaxl ext tab 7 x 45mm (part # 179732745 lot # 256559) was received at us cq.Upon visual inspection it was noticed that the broken tip of the mmsi driver shaft for red scrw was lodged inside the shank of the screw.No other issues were identified on the device.Functional test: upon the functional test, it was observed that the driver shaft tip was lodged inside the screw shank and it was unable to be removed.The lodged condition of the broken tip could have resulted in the alleged complaint condition.Complaint replication? yes dimensional inspection: due to post manufacturing damage and confirmed jammed/ seized on the device the dimensional inspection was not performed.Document/specification review: drawing(s) reviewed: (current & manufactured revisions) no issues complaint confirmed? no conclusion: the overall complaint was not confirmed for the received si polyaxl ext tab 7 x 45mm (part # 179732745 lot # 256559).There was no defect found on the device itself.The possible root cause for the complaint condition could be that the logged condition of the broken driver shaft tip within the screw shank could have restricted the further advancement of the screw, hence needed to be removed from the patient.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.Device history the dhr of product code 179732745, lot 256559, was reviewed and no non-conformance was observed during the manufacturing process.The product was released on september 21, 2019.Qty.67 the dhr was electronically reviewed.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.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.

• Brand Name: SI POLYAXL EXT TAB 7 X 45MM
• 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: 10205691
• Report Number: 1526439-2020-01274
• Device Sequence Number: 2107579
• Product Code: NKB
• UDI-Device Identifier: 10705034074047
• UDI-Public: (01)10705034074047
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160904
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/30/2020

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: 179732745
• Device Catalogue Number: 179732745
• Device Lot Number: 256559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: 06/16/2020
• Supplement Date Received by Manufacturer: 06/30/2020; 07/30/2020; 08/03/2020; 08/28/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 07/20/2020; 08/19/2020; 08/26/2020; 09/01/2020
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN SCREWDRIVERS