MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC CD HORIZON X10 CROSSLINK; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	8110530
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Neither the device nor films of applicable imaging studies were returned to the manufacturer for evaluation.Therefore, we are unable to determine the definitive cause of the reported event.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a healthcare professional via a field contact regarding a product used in spinal therapy.It was reported that, at the time of removing cross link, the tip of the driver of the removal kit broke.There were no patient symptoms or complications as a result of this event.All the implant products were removed, no fragment of driver tip remained in the body.The product was attempted to be removed as the bone union was achieved.The sales rep only attended when dividing the instrument, and he/she attended another operation in a different operation room.Later the sales rep heard about the damage after the distributor finished cleaning up.The product will be returned and will be replaced.
Additional Manufacturer Narrative
H3: product analysis: visual and optical examination confirmed approximately 2.5 mm of instrument tip has been broken off, consistent with interface during usage.The remaining tip has been twisted, consistent with torsional overload.Fracture surface analysis reveals a fairly flat fracture surface and circular material movement, consistent with torsional overload.This type of damage is consistent with torsional overload.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.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 via a field contact regarding a product used in spinal therapy.It was reported that, at the time of removing cross link, the tip of the driver of the removal kit broke.There were no patient symptoms or complications as a result of this event.All the implant products were removed, no fragment of driver tip remained in the body.The product was attempted to be removed as the bone union was achieved.The sales rep only attended when dividing the instrument, and he/she attended another operation in a different operation room.Later the sales rep heard about the damage after the distributor finished cleaning up.The product will be returned and will be replaced.It was reported that lot number and levels implanted are unknown.Type of initial surgery: lumbar posterior fusion.

• Brand Name: CD HORIZON X10 CROSSLINK
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• MDR Report Key: 10493077
• Report Number: 1030489-2020-01192
• Device Sequence Number: 2199119
• Product Code: LXH
• UDI-Device Identifier: 00721902744600
• UDI-Public: 00721902744600
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 01/15/2021

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: 8110530
• Device Catalogue Number: 8110530
• Device Lot Number: SW11C520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 01/04/2021
• Initial Report FDA Received Date: 09/04/2020
• Supplement Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR