MAUDE Adverse Event Report: EXACTECH, INC. SPECIAL SAMSOE PIN PULLER; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Model Number SPECIAL SAMSOE PIN PULLER

Device Problem Misassembled (1398)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

The evaluation noted that revision reported was likely the result of weld degradation due to numerous surgical uses and subsequent sterilization cycles, which resulted in ultimate fracture of the dowel pin from the pin lever.The most probable root cause to the reported product failure is associated with undesired damage or breakage in a solder joint of materials used in the device construction.

Event Description

As reported, sales rep.Sent picture of a special pin puller that was found disassembled after use.The surgery was completed, and nothing was left in the patient.The scrub texh felt he damaged the pin puller when disassembling instruments in decontamination.He guaranteed all was present.The device will be returned.

• Brand Name: SPECIAL SAMSOE PIN PULLER
• Type of Device: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: kate jacobson ; 2320 nw 66 court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 11327744
• MDR Text Key: 232230517
• Report Number: 1038671-2021-00040
• Device Sequence Number: 1
• Product Code: JWH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2021

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
• Device Operator: Health Professional
• Device Model Number: SPECIAL SAMSOE PIN PULLER
• Device Catalogue Number: SK-031354
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/15/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1