MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. OSTEOSET PELLET INJECTOR; FILLER, BONE VOID, CALCIUM COMPOUND

Model Number	87004805
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device will not be returned.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that the patient underwent a reduction and internal fixation of a femoral shaft fracture and bone graft surgery under general anesthesia.After insertion of the artificial bone graft it was found that a piece of the plastic from the injector was missing.The surgeon failed to find the broken piece and closed the wound of the patient.

• Brand Name: OSTEOSET PELLET INJECTOR
• Common Device Name: FILLER, BONE VOID, CALCIUM COMPOUND
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• MDR Report Key: 12302375
• Report Number: 0001043534-2021-00138
• Device Sequence Number: 3532421
• Product Code: MQV
• UDI-Device Identifier: 00840420133649
• UDI-Public: 00840420133649
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K963562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2021

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 Expiration Date: 03/31/2022
• Device Model Number: 87004805
• Device Catalogue Number: 87004805
• Device Lot Number: 1557862
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 08/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR