MAUDE Adverse Event Report: PIONEER SURGICAL TECHNOLOGIES ZIMMER® CANNULATED SCREW SYSTEM; 7.0MM CAN SCR FULLTHR 150MM LG

Model Number	00-1147-150-72
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Abdominal Pain (1685)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complaint was investigated and evaluated without the returned device or confirmation of the causal relationship between the device and event.No lot information was provided; therefore, a device history record review could not be performed to determine related events or nonconformities present within the lot.The device remained implanted and a direct evaluation could not be performed.The complainant confirmed that no further information was made available at this time.The root cause and confirmation of device malfunction cannot be confirmed at this time.
Event or Problem Description
It was reported by the patient's legal counsel that the patient had a left hemipelvis orif on (b)(6) 2018 with a zimmer recon plate and synthes screws.Subsequently, it was reported that an unspecified implant broke or failed resulting in painful fragments in the patient's abdomen.No further information has been provided at this time.

• Brand Name: ZIMMER® CANNULATED SCREW SYSTEM
• Common Device Name: 7.0MM CAN SCR FULLTHR 150MM LG
• Manufacturer (Section D): PIONEER SURGICAL TECHNOLOGIES; 375 river park circle; marquette MI 49855
• Manufacturer (Section G): PIONEER SURGICAL TECHNOLOGIES; 375 river park circle; marquette MI 49855
• Manufacturer Contact: tamara lewis ; 375 river park circle; marquette, MI 89855 ; 9062269909
• MDR Report Key: 22809151
• Report Number: 1833824-2025-43531
• Device Sequence Number: 15693367
• Product Code: HWC
• UDI-Device Identifier: 00846468073329
• UDI-Public: 00846468073329
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K003496
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2025

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: Lay User/Patient
• Device Model Number: 00-1147-150-72
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 08/14/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Race: White