MAUDE Adverse Event Report: SYNTHES TRAUMA : PROSIDYAN, INC. FIBERGRAFT BG PUTTY; FILLER, BONE VOID, CALCIUM COMPOUND

Catalog Number	78000110
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported that fibergraft bg putty large 11cc was unusable as it was hardened within the syringe upon opening during an intraoperative event.The event occurred during a procedure for femur non-union.There was no surgical delay due to the reported issue, as another product was opened and the procedure was successfully completed.No patient consequences or impact were reported.

• Brand Name: FIBERGRAFT BG PUTTY
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): SYNTHES TRAUMA : PROSIDYAN, INC.; 41 spring st, suite 107; new providence NJ
• Manufacturer Contact: elba bello ; 41 spring st, suite 107; new providence, NJ 07974 ; 9083863534
• MDR Report Key: 25015044
• Report Number: 3011015097-2026-00007
• Device Sequence Number: 9587364
• Product Code: MQV
• UDI-Device Identifier: 00856879006731
• UDI-Public: (01)00856879006731(10)2311301
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K170306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: 78000110
• Device Lot Number: 2311301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2026
• Supplement Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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