MAUDE Adverse Event Report: MSD BARTLETT MFG CD HORIZON SPINAL SYSTEM; SCREWDRIVER

Model Number	7570923
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product was returned and analysis is yet to begin.A follow-up report will be sent once analysis is completed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient implanted with a screw using drivers for a spondylolisthesis l4-5 (intra-op).It was reported tips of both drivers broke off into the head of the screw.There was no patient symptoms or complications as a result of this event.The instruments broke and there were fragments of the instruments remaining in the patient i.E.The tips of the broken drivers are in the screw head.The pre- op diagnosis was spondylolisthesis l4-5.No additional treatment or surgery performed as a result of this event.No further complications were reported/ anticipated.
Additional Manufacturer Narrative
G3: correction as foreign was incorrectly checked.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
D2: correction in product code.G3: correction as foreign was incorrectly checked.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
H3: product analysis found that visually confirmed that the instrument tip has been broken off, consistent with interface during usage.Inspection of the material hardness confirmed conformance to print specification.Fracture surface analysis of both instruments identified a fairly flat fracture surface and circular material movement, consistent with torsional overload.This is consistent with torsional overload.H6: analysis resulted in change in eval.Code result.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional (hcp) via a medtronic representative regarding a patient implanted with a screw using drivers for a spondylolisthesis l4-5.It was reported tips of both drivers broke off into the head of the screw.There was no patient symptoms or complications as a result of this event.The instruments broke and there were fragments of the instruments remaining in the patient i.E.The tips of the broken drivers are in the screw head.The pre- op diagnosis was spondylolisthesis l4-5.No additional treatment or surgery performed as a result of this event.The products were replaced by medtronic products.No further complications were reported/ anticipated.

• Brand Name: CD HORIZON SPINAL SYSTEM
• Common Device Name: SCREWDRIVER
• Manufacturer (Section D): MSD BARTLETT MFG; 2975 brother blvd; bartlett TN 38133
• MDR Report Key: 10633836
• Report Number: 1030489-2020-01383
• Device Sequence Number: 17007025
• Product Code: HXX
• UDI-Device Identifier: 00613994236012
• UDI-Public: 00613994236012
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7570923
• Device Catalogue Number: 7570923
• Device Lot Number: RS08B003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 10/21/2020; 10/21/2020; 09/16/2020
• Initial Report FDA Received Date: 10/06/2020
• Supplement Report FDA Received Date: 10/26/2020; 10/26/2020; 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 72 YR