MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO HUDSON/MODIFIED TRINKLE ATTACHMENT; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	6203135000
Medical Device Problem Codes	Fracture (1260); Fitting Problem (2183)
Health Effect - Clinical Codes	Abrasion (1689); Infiltration into Tissue (1931)
Date of Event	05/08/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the user facility that the surgeon was reaming the acetabular wall when something in the drill reamer broke, which caused the reamer to start rotating oblong causing the reamer to damage the anterior wall.The surgeon stopped when he felt the reamer break in his hand and there was an additional hour to surgery to facilitate priming for alternate company shell/liner.
Event or Problem Description
It was reported by the user facility that the surgeon was reaming the acetabular wall when something in the drill reamer broke, which caused the reamer to start rotating oblong causing the reamer to damage the anterior wall.The surgeon stopped when he felt the reamer break in his hand and there was an additional hour to surgery to facilitate priming for alternate company shell/liner.
Additional Manufacturer Narrative
Supplemental report submitted to document device evaluation results.Corrected data in d9.

• Brand Name: HUDSON/MODIFIED TRINKLE ATTACHMENT
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 11951573
• Report Number: 3015967359-2021-01063
• Device Sequence Number: 13741505
• Product Code: HWE
• UDI-Device Identifier: 04546540501684
• UDI-Public: 04546540501684
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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: No Information
• Device Model Number: 6203135000
• Device Catalogue Number: 6203135000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2021
• Supplement Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 70 YR