MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC VALOR FLEX REAMER HEAD 12.5MM

Catalog Number	4150006125
Medical Device Problem Codes	Break (1069); Fracture (1260); Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the head of the reamer broke during the operation and remained in the tibia.Reamer was removed from the patient, but caused a dangerous situation.
Additional Manufacturer Narrative
Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
Event or Problem Description
It was reported that the head of the reamer broke during the operation and remained in the tibia.Reamer was removed from the patient, but caused a dangerous situation.
Additional Manufacturer Narrative
The complaint could be confirmed, since the product was returned for evaluation and matches the alleged failure.The device inspection revealed the following: visual examination of the received product shows that the return reamer head is in a very bad condition, and is no longer usable.All 4 cutting edges are completely dull.Some sections of the cutting edges show brows, from running the reamer head backwards, also the edge between flute and land got damaged from running backwards.The recess of the reamer head is badly damaged from use, as it showing dents and deformations.Even though the part was returned in one piece, it unfortunately does not show a lot number and the customer did not provide us with a lot number.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.Indications of material, manufacturing, or design related problems were unable to be identified as the lot number was not communicated.Based on investigation, the root cause was attributed to a use related issue.If more information is provided, the case will be reassessed.

• Brand Name: VALOR FLEX REAMER HEAD 12.5MM
• Common Device Name: REAMER
• 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 17878626
• Report Number: 3010667733-2023-00592
• Device Sequence Number: 7417985
• Product Code: HTO
• UDI-Device Identifier: 00889797035484
• UDI-Public: 00889797035484
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 03/07/2024

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 Catalogue Number: 4150006125
• Device Lot Number: UNKNOWN
• 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: 09/12/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown