MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC ALLOMATRIX INJECTABLE PUTTY 1.0CC; FILLER, BONE VOID, CALCIUM COMPOUND

Catalog Number	86000100
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: "a hair was found in the package, and the surgeon refused to use the product.Finally, a new product was used to complete the surgery.".
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 vinyl shrink wrap and the outer carton packaging got opened.Furthermore, the examination showed that a hair was lodged between the blister pack and the sealing film; however, the packaging is still completely sealed.Inspection of the received information/evidences are done or will be done, in the proceedings of the nc.Based on investigation, the root cause was attributed to a manufacturing issue.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "a hair was found in the package, and the surgeon refused to use the product.Finally, a new product was used to complete the surgery.".

• Brand Name: ALLOMATRIX INJECTABLE PUTTY 1.0CC
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• 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: 23586461
• Report Number: 3010667733-2025-01366
• Device Sequence Number: 15779182
• Product Code: MQV
• UDI-Device Identifier: 00840420133557
• UDI-Public: (01)00840420133557(11)250326(17)291204(21)1816708017
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K040980
• 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): 02/09/2026

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: 86000100
• Device Lot Number: 1816708017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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