MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE WRENCH TIB STEM 14

Catalog Number	200380001
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	01/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the product was thrown away in the trash because the reamer head piece 14mm (200046001) was broken off on the reamer rod (200089).The wrench slid a little bit and broke the medial mal or distal tibia and we had to fix the distal tibia with orif with a medial mal plate.The product was thrown away in the trash because the reamer head piece 14mm (200046001) was broken off on the reamer rod (200089).The wrench slid a little bit and broke the medial mal or distal tibia and we had to fix the distal tibia with orif with a medial mal plate".
Additional Manufacturer Narrative
Upon completion of the investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "the product was thrown away in the trash because the reamer head piece 14mm (200046001) was broken off on the reamer rod(200089).The wrench slid a little bit and broke the medial mal or distal tibia and we had to fix the distal tibia with orif with a medial mal plate.The product was thrown away in the trash because the reamer head piece 14mm (200046001) was broken off on the reamer rod(200089).The wrench slid a little bit and broke the medial mal or distal tibia and we had to fix the distal tibia with orif with a medial mal plate".
Additional Manufacturer Narrative
The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidence was provided.The investigation revealed the following: device inspection was not possible because the affected device was not returned for investigation.Review of the image showed that the instrument is in a well-used condition, with scratches, dents, and deformation.For a more in-depth investigation and detailed statement, we need to receive the product back.The investigation revealed the following: a device inspection was not possible since the affected device was not returned for investigation.An inspection of the image has shown that the instrument is in a well-used condition, with scratched dents and deformation.For a more in-depth investigation and a detailed statement, we need to receive the product back.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required currently.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing, or design-related problems were found during the investigation.More detailed information about the complaint event must be available to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: INBONE WRENCH TIB STEM 14
• Common Device Name: WRENCH
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24372787
• Report Number: 3010667733-2026-00133
• Device Sequence Number: 4875367
• Product Code: HXC
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2026

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 Catalogue Number: 200380001
• Device Lot Number: 2844221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown