MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE DOME STRIKE TIP SULC; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	IB200031
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.Device disposition unknown.
Event or Problem Description
Stryker rep reported that the impactor broke during the case.
Additional Manufacturer Narrative
Correction: d3 manufacturer entity, d9, h3, h6 method, results, conclusion, clinical code, g1 manufacturing site.This event was reported in error due to a lack of information available.With the new product information and event description, this event should not have been reported.Please note that at the time of the initial report the part number was unknown and suspected to be a device manufactured in selzach.It has since been discovered that the device was manufactured by wright which would be under fda registration # 3010667733.The reported event could be confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: the received inbone dome strike tip was found to be broken.This is a complete separation of the component under service loading that renders the component nonfunctional.The fractography indicates it to be a brittle fracture under sudden overloading.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿surgical instruments and instrument cases are susceptible to damage from prolonged use, and through misuse or rough handling.Care must be taken to avoid compromising their exacting performance.Careful inspection and functional test of the instrument before use is the best method of determining the end of serviceable life.¿ based on investigation, the root cause was attributed to a user related issue.The failure was caused due to sudden overloading on the instrument leading to brittle fracture/breakage during implantation.If any further information is provided, the complaint report will be updated.
Event or Problem Description
Stryker rep reported that the impactor broke during the case.No pieces of the impactor remained in the patient.

• Brand Name: INBONE DOME STRIKE TIP SULC
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; postfach; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; postfach; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 14427467
• Report Number: 0008031020-2022-00231
• Device Sequence Number: 5604277
• Product Code: LXH
• UDI-Device Identifier: 00889797047999
• UDI-Public: 00889797047999
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2022

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: IB200031
• Device Catalogue Number: IB200031
• Device Lot Number: 2433999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 08/12/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown